Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

January 16, 2017 updated by: GlaxoSmithKline

A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Study Overview

Status

Completed

Conditions

Prostatic Hyperplasia

Intervention / Treatment

Detailed Description

A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.

Study Type

Interventional

Enrollment (Actual)

4844

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

- - - GSK Investigational Site
Argentina
- - Buenos Aires, Argentina, 1111
    - GSK Investigational Site
  - Buenos Aires, Argentina, 1120
    - GSK Investigational Site
  - Buenos Aires, Argentina, 1416
    - GSK Investigational Site
  - Buenos Aires, Argentina, C1181ACI
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Argentina, 1405
    - GSK Investigational Site
  - Ciudad de Buenos Aires, Argentina, 1118
    - GSK Investigational Site
Belgium
- - Antwerpen, Belgium, 2020
    - GSK Investigational Site
  - Brussel, Belgium, 1090
    - GSK Investigational Site
  - Brussels, Belgium, 1070
    - GSK Investigational Site
  - Edegem, Belgium, 2650
    - GSK Investigational Site
  - Genk, Belgium, 3600
    - GSK Investigational Site
  - La Louvière, Belgium, 7100
    - GSK Investigational Site
  - Liège, Belgium, 4000
    - GSK Investigational Site
  - Roeselare, Belgium, 8800
    - GSK Investigational Site
Brazil
- - Rio de Janeiro, Brazil, 20 551-030
    - GSK Investigational Site
  - São Paulo, Brazil, 04262-000
    - GSK Investigational Site
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30130-008
    - GSK Investigational Site
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - GSK Investigational Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - GSK Investigational Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
    - GSK Investigational Site
Bulgaria
- - Pleven, Bulgaria, 5800
    - GSK Investigational Site
  - Sofia, Bulgaria, 1606
    - GSK Investigational Site
  - Sofia, Bulgaria, 1431/1000
    - GSK Investigational Site
  - Sofia, Bulgaria, 1000
    - GSK Investigational Site
  - Varna, Bulgaria, 9002
    - GSK Investigational Site
Canada
- British Columbia
  - Surrey, British Columbia, Canada, V3V 1N1
    - GSK Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3C 0N2
    - GSK Investigational Site
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - GSK Investigational Site
- Newfoundland and Labrador
  - Saint John's, Newfoundland and Labrador, Canada, A1B 4S8
    - GSK Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 3A7
    - GSK Investigational Site
  - Kentville, Nova Scotia, Canada, B4N 4K9
    - GSK Investigational Site
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - GSK Investigational Site
  - Brantford, Ontario, Canada, N3R 4N3
    - GSK Investigational Site
  - Courtice, Ontario, Canada, L1E 3C3
    - GSK Investigational Site
  - Guelph, Ontario, Canada, N1H 5J1
    - GSK Investigational Site
  - Hamilton, Ontario, Canada, L8N 4A6
    - GSK Investigational Site
  - Kingston, Ontario, Canada, K7L 2V7
    - GSK Investigational Site
  - London, Ontario, Canada, N6A 4V2
    - GSK Investigational Site
  - London, Ontario, Canada, M6A 4G5
    - GSK Investigational Site
  - North Bay, Ontario, Canada, P1B 7K8
    - GSK Investigational Site
  - Oakville, Ontario, Canada, L6H 3P1
    - GSK Investigational Site
  - Oshawa, Ontario, Canada, L1H 7K4
    - GSK Investigational Site
  - Ottawa, Ontario, Canada, K1Y 4E9
    - GSK Investigational Site
  - Scarborough, Ontario, Canada, M1S 4V5
    - GSK Investigational Site
  - Scarborough, Ontario, Canada, M1P 2T7
    - GSK Investigational Site
  - Sudbury, Ontario, Canada, P3E 4T3
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5T 2S8
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M6A 3B5
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M4C 5T2
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M2K 2W1
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M6S 4W4
    - GSK Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H3A 1A1
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H2X 1N8
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H3S 1Z1
    - GSK Investigational Site
  - Saint Charles-Borromee, Quebec, Canada, J6E 6J2
    - GSK Investigational Site
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - GSK Investigational Site
  - St-Jerome, Quebec, Canada, J7Z 5T3
    - GSK Investigational Site
  - Trois Rivieres, Quebec, Canada, G9A 3V7
    - GSK Investigational Site
Czech Republic
- - Hradec Kralove, Czech Republic, 536 00
    - GSK Investigational Site
  - Ostrava - Poruba, Czech Republic, 708 52
    - GSK Investigational Site
  - Praha 3, Czech Republic, 130 00
    - GSK Investigational Site
  - Praha 5, Czech Republic, 150 18
    - GSK Investigational Site
  - Praha 8, Czech Republic, 180 71
    - GSK Investigational Site
  - Roudnice nad Labem, Czech Republic, 413 01
    - GSK Investigational Site
Denmark
- - Aalborg, Denmark, 9100
    - GSK Investigational Site
  - Aarhus N, Denmark, 8200
    - GSK Investigational Site
  - Fredericia, Denmark, 7000
    - GSK Investigational Site
  - Randers, Denmark, 8900
    - GSK Investigational Site
Estonia
- - Tallinn, Estonia, 13419
    - GSK Investigational Site
  - Tallinn, Estonia, 1162
    - GSK Investigational Site
  - Tartu, Estonia, 51014
    - GSK Investigational Site
  - Tartu, Estonia
    - GSK Investigational Site
Finland
- - Helsinki, Finland, 00150
    - GSK Investigational Site
  - Kouvola, Finland, 45200
    - GSK Investigational Site
  - Kuopio, Finland, 70100
    - GSK Investigational Site
  - Pietarsaari, Finland, 68600
    - GSK Investigational Site
  - Tampere, Finland, 33520
    - GSK Investigational Site
France
- - Agny, France, 62217
    - GSK Investigational Site
  - Angers, France, 49000
    - GSK Investigational Site
  - Annecy, France, 74000
    - GSK Investigational Site
  - Arras, France, 62000
    - GSK Investigational Site
  - Athis Mons Cedex, France, 91200
    - GSK Investigational Site
  - Besançon, France, 25000
    - GSK Investigational Site
  - Bouchemaine, France, 49080
    - GSK Investigational Site
  - Broglie, France, 27270
    - GSK Investigational Site
  - Castelneau Le Nez, France, 34170
    - GSK Investigational Site
  - Chambery, France, 73000
    - GSK Investigational Site
  - Chambéry, France, 73000
    - GSK Investigational Site
  - Chilly Mazarin, France, 91380
    - GSK Investigational Site
  - Cournonterral, France, 34460
    - GSK Investigational Site
  - Créteil cedex, France, 94010
    - GSK Investigational Site
  - Domarin, France, 38300
    - GSK Investigational Site
  - Epinay sur Orge, France, 91360
    - GSK Investigational Site
  - Evreux, France, 27000
    - GSK Investigational Site
  - Evreux Cedex, France, 27025
    - GSK Investigational Site
  - Gif-sur-Yvette, France, 91190
    - GSK Investigational Site
  - Grenoble, France, 38100
    - GSK Investigational Site
  - La Seyne sur Mer, France, 83500
    - GSK Investigational Site
  - Lamarque, France, 33460
    - GSK Investigational Site
  - Laval, France, 53000
    - GSK Investigational Site
  - Le Brusc, France, 83140
    - GSK Investigational Site
  - Le Kremlin-Bicêtre, France, 94275
    - GSK Investigational Site
  - Les Mureaux, France, 78130
    - GSK Investigational Site
  - Lesparre Médoc, France, 33340
    - GSK Investigational Site
  - Linas, France, 91310
    - GSK Investigational Site
  - Longpont sur Orge, France, 91310
    - GSK Investigational Site
  - Lyon, France, 69008
    - GSK Investigational Site
  - Melun, France, 77007
    - GSK Investigational Site
  - Meudon, France, 92190
    - GSK Investigational Site
  - Meylan, France, 38240
    - GSK Investigational Site
  - Mont de Marsan, France, 40000
    - GSK Investigational Site
  - Montauban, France, 82017
    - GSK Investigational Site
  - Montpelier, France, 34000
    - GSK Investigational Site
  - Montpellier, France, 34000
    - GSK Investigational Site
  - Montpellier, France, 34100
    - GSK Investigational Site
  - Orléans Cedex 2, France, 45067
    - GSK Investigational Site
  - Paris, France, 75019
    - GSK Investigational Site
  - Pontonx Sur Adour, France, 40465
    - GSK Investigational Site
  - Roanne, France, 42300
    - GSK Investigational Site
  - Saint Chamond, France, 42400
    - GSK Investigational Site
  - Saint Denis, France, 93200
    - GSK Investigational Site
  - Saint Galmier, France, 42330
    - GSK Investigational Site
  - Saint Germain Lespinasse, France, 42640
    - GSK Investigational Site
  - Saint Sebastien de Morsent, France, 27180
    - GSK Investigational Site
  - Saint-Egrève, France, 38120
    - GSK Investigational Site
  - Saint-Georges d'Orques, France, 34680
    - GSK Investigational Site
  - Sainte Suzanne, France, 53270
    - GSK Investigational Site
  - Sanary, France, 83110
    - GSK Investigational Site
  - Sarlat la Canéda, France, 24200
    - GSK Investigational Site
  - Seysses, France, 31600
    - GSK Investigational Site
  - Six-Fours les Plages, France, 83140
    - GSK Investigational Site
  - Suresnes Cedex, France, 92151
    - GSK Investigational Site
  - Toulon, France, 83200
    - GSK Investigational Site
  - Tours, France, 37044
    - GSK Investigational Site
  - Vaucresson, France, 92420
    - GSK Investigational Site
  - Verneuil-sur-Seine, France, 78480
    - GSK Investigational Site
  - Villejuif Cedex, France, 94804
    - GSK Investigational Site
  - Villeneuve-Les-Maguelone, France, 34750
    - GSK Investigational Site
  - Vourey, France, 38210
    - GSK Investigational Site
- Nord-Pas-de-Calais
  - Bully Les Mines, Nord-Pas-de-Calais, France, 62160
    - GSK Investigational Site
Germany
- - Berlin, Germany, 13055
    - GSK Investigational Site
  - Berlin, Germany, 13125
    - GSK Investigational Site
  - Berlin, Germany, 12167
    - GSK Investigational Site
  - Berlin, Germany, 14197
    - GSK Investigational Site
  - Berlin, Germany, 10627
    - GSK Investigational Site
  - Berlin, Germany, 13053
    - GSK Investigational Site
  - Berlin, Germany, 13439
    - GSK Investigational Site
  - Berlin, Germany, 12347
    - GSK Investigational Site
  - Berlin, Germany, 10719
    - GSK Investigational Site
  - Berlin, Germany, 12681
    - GSK Investigational Site
  - Hamburg, Germany, 20253
    - GSK Investigational Site
  - Hamburg, Germany, 22415
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Aalen, Baden-Wuerttemberg, Germany, 73430
    - GSK Investigational Site
  - Freiburg, Baden-Wuerttemberg, Germany, 79106
    - GSK Investigational Site
  - Konstanz, Baden-Wuerttemberg, Germany, 78464
    - GSK Investigational Site
  - Mosbach, Baden-Wuerttemberg, Germany, 74821
    - GSK Investigational Site
  - Rottweil, Baden-Wuerttemberg, Germany, 78628
    - GSK Investigational Site
  - Stockach, Baden-Wuerttemberg, Germany, 78333
    - GSK Investigational Site
- Bayern
  - Aichach, Bayern, Germany, 86551
    - GSK Investigational Site
  - Amberg, Bayern, Germany, 92224
    - GSK Investigational Site
  - Augsburg, Bayern, Germany, 86150
    - GSK Investigational Site
  - Graefeling, Bayern, Germany, 82166
    - GSK Investigational Site
  - Neu-Ulm, Bayern, Germany, 89231
    - GSK Investigational Site
  - Schongau, Bayern, Germany, 86956
    - GSK Investigational Site
  - Wertingen, Bayern, Germany, 86637
    - GSK Investigational Site
- Brandenburg
  - Hagenow, Brandenburg, Germany, 19230
    - GSK Investigational Site
  - Lauchhammer, Brandenburg, Germany, 01979
    - GSK Investigational Site
  - Oranienburg, Brandenburg, Germany, 16515
    - GSK Investigational Site
  - Senftenberg, Brandenburg, Germany, 01968
    - GSK Investigational Site
- Hessen
  - Alzenau, Hessen, Germany, 63755
    - GSK Investigational Site
  - Frankfurt, Hessen, Germany, 60326
    - GSK Investigational Site
  - Fulda, Hessen, Germany, 36037
    - GSK Investigational Site
  - Giessen, Hessen, Germany, 35390
    - GSK Investigational Site
  - Kassel, Hessen, Germany, 34123
    - GSK Investigational Site
  - Koenigstein, Hessen, Germany, 61462
    - GSK Investigational Site
  - Marburg, Hessen, Germany, 35039
    - GSK Investigational Site
  - Schwalbach, Hessen, Germany, 65824
    - GSK Investigational Site
- Mecklenburg-Vorpommern
  - Grimmen, Mecklenburg-Vorpommern, Germany, 18507
    - GSK Investigational Site
  - Parchim, Mecklenburg-Vorpommern, Germany, 19370
    - GSK Investigational Site
- Niedersachsen
  - Delmenhorst, Niedersachsen, Germany, 27753
    - GSK Investigational Site
  - Holzminden, Niedersachsen, Germany, 37603
    - GSK Investigational Site
  - Oldenburg, Niedersachsen, Germany, 26121
    - GSK Investigational Site
  - Osnabrueck, Niedersachsen, Germany, 49074
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Duelmen, Nordrhein-Westfalen, Germany, 48249
    - GSK Investigational Site
  - Stadtlohn, Nordrhein-Westfalen, Germany, 48703
    - GSK Investigational Site
- Rheinland-Pfalz
  - Koblenz, Rheinland-Pfalz, Germany, 56068
    - GSK Investigational Site
- Sachsen
  - Hohenstein-Ernsttal, Sachsen, Germany, 09337
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04105
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04109
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04277
    - GSK Investigational Site
- Sachsen-Anhalt
  - Halle, Sachsen-Anhalt, Germany, 06114
    - GSK Investigational Site
  - Hettstedt, Sachsen-Anhalt, Germany, 06333
    - GSK Investigational Site
  - Merseburg, Sachsen-Anhalt, Germany, 06217
    - GSK Investigational Site
- Schleswig-Holstein
  - Husum, Schleswig-Holstein, Germany, 25813
    - GSK Investigational Site
  - Kiel, Schleswig-Holstein, Germany, 24103
    - GSK Investigational Site
- Thueringen
  - Apolda, Thueringen, Germany, 99510
    - GSK Investigational Site
Greece
- - Athens, Greece, 115 21
    - GSK Investigational Site
  - Athens, Greece, 115 22
    - GSK Investigational Site
  - Athens, Greece, 15126
    - GSK Investigational Site
  - Athens, Greece, 154 52
    - GSK Investigational Site
  - Patra, Greece, 265 00
    - GSK Investigational Site
  - Polygyros, Greece, 63 100
    - GSK Investigational Site
  - Thassaloniki, Greece, 564 34
    - GSK Investigational Site
Hungary
- - Budapest, Hungary, 1036.
    - GSK Investigational Site
  - Sopron, Hungary, 9400
    - GSK Investigational Site
  - Székesfehérvár, Hungary, 8000
    - GSK Investigational Site
  - Veszprém, Hungary, 8200
    - GSK Investigational Site
Iceland
- - Reykjavik, Iceland, 101
    - GSK Investigational Site
Israel
- - Haifa, Israel, 31048
    - GSK Investigational Site
  - Haifa, Israel
    - GSK Investigational Site
  - Holon, Israel, 58100
    - GSK Investigational Site
  - Kfar Saba, Israel, 44281
    - GSK Investigational Site
  - Ramat Gan, Israel, 52621
    - GSK Investigational Site
  - Zrifin, Israel, 70300
    - GSK Investigational Site
Italy
- Calabria
  - Catanzaro, Calabria, Italy, 88100
    - GSK Investigational Site
- Campania
  - Avellino, Campania, Italy, 83100
    - GSK Investigational Site
  - Castellamare di Stabia (NA), Campania, Italy, 80053
    - GSK Investigational Site
  - Napoli, Campania, Italy, 80131
    - GSK Investigational Site
  - San Felice a Cancello Caserta, Campania, Italy, 81027
    - GSK Investigational Site
  - Torre del Greco (NA), Campania, Italy, 80059
    - GSK Investigational Site
- Emilia-Romagna
  - Modena, Emilia-Romagna, Italy, 41100
    - GSK Investigational Site
- Friuli-Venezia-Giulia
  - Udine, Friuli-Venezia-Giulia, Italy, 33100
    - GSK Investigational Site
- Lazio
  - Roma, Lazio, Italy, 00189
    - GSK Investigational Site
- Liguria
  - Genova, Liguria, Italy, 16128
    - GSK Investigational Site
- Lombardia
  - Lecco, Lombardia, Italy, 23100
    - GSK Investigational Site
  - Milano, Lombardia, Italy, 20132
    - GSK Investigational Site
- Piemonte
  - Ivrea (TO), Piemonte, Italy, 10015
    - GSK Investigational Site
  - Novara, Piemonte, Italy, 28100
    - GSK Investigational Site
  - Torino, Piemonte, Italy, 10126
    - GSK Investigational Site
- Sardegna
  - Cagliari, Sardegna, Italy, 09134
    - GSK Investigational Site
- Sicilia
  - Acireale (CT), Sicilia, Italy, 95124
    - GSK Investigational Site
- Toscana
  - Bagno a Ripoli (FI), Toscana, Italy, 50126
    - GSK Investigational Site
  - Firenze, Toscana, Italy, 50139
    - GSK Investigational Site
  - Siena, Toscana, Italy, 53100
    - GSK Investigational Site
- Veneto
  - Portogruaro (VE), Veneto, Italy, 30026
    - GSK Investigational Site
Korea, Republic of
- - Pusan, Korea, Republic of, 602-739
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 138-736
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-720
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-710
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 150-015
    - GSK Investigational Site
Lithuania
- - Kaunas, Lithuania, LT-47144
    - GSK Investigational Site
  - Kaunas, Lithuania, LT-49287
    - GSK Investigational Site
  - Klaipeda, Lithuania, LT-92288
    - GSK Investigational Site
  - Klaipeda, Lithuania, LT-92231
    - GSK Investigational Site
  - Vilnius, Lithuania, LT-10207
    - GSK Investigational Site
Mexico
- - Mexico, Mexico, 06700
    - GSK Investigational Site
  - Mexico DF, Mexico, 06720
    - GSK Investigational Site
  - Mexico, D.F., Mexico, 14050
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44340
    - GSK Investigational Site
  - Zapopan, Jalisco, Mexico, 45170
    - GSK Investigational Site
  - Zapopan, Jalisco, Jalisco, Mexico, 45100
    - GSK Investigational Site
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - GSK Investigational Site
  - Amstelveen, Netherlands, 1186 AM
    - GSK Investigational Site
  - Amsterdam, Netherlands, 1105 AZ
    - GSK Investigational Site
  - Amsterdam, Netherlands, 1034 CS
    - GSK Investigational Site
  - Arnhem, Netherlands, 6842 CV
    - GSK Investigational Site
  - Den Haag, Netherlands, 2566 MJ
    - GSK Investigational Site
  - Doetinchem, Netherlands, 7009 BL
    - GSK Investigational Site
  - Enschede, Netherlands, 7511JX
    - GSK Investigational Site
  - Etten-leur, Netherlands, 4872 LA
    - GSK Investigational Site
  - Groningen, Netherlands, 9713 GZ
    - GSK Investigational Site
  - Groningen, Netherlands, 9721 SW
    - GSK Investigational Site
  - Heerlen, Netherlands, 6419 PC
    - GSK Investigational Site
  - Hilversum, Netherlands, 1213 XZ
    - GSK Investigational Site
  - Hoofddorp, Netherlands, 2134 TM
    - GSK Investigational Site
  - Maastricht, Netherlands, 6229 HX
    - GSK Investigational Site
  - Tilburg, Netherlands, 5022 GC
    - GSK Investigational Site
  - Tilburg, Netherlands, 5042 AD
    - GSK Investigational Site
  - Veldhoven, Netherlands, 5504 DB
    - GSK Investigational Site
  - Winterswijk, Netherlands, 7101 BN
    - GSK Investigational Site
  - Zwijndrecht, Netherlands, 3331 LZ
    - GSK Investigational Site
Norway
- - Aalesund, Norway, N-6026
    - GSK Investigational Site
  - Bergen, Norway, 5094
    - GSK Investigational Site
  - Bodø, Norway, N-8009
    - GSK Investigational Site
  - Haugesund, Norway, 5507
    - GSK Investigational Site
  - Moelv, Norway, N-2390
    - GSK Investigational Site
  - Nøtterøy, Norway, 3128
    - GSK Investigational Site
  - Oslo, Norway, 0257 OSLO
    - GSK Investigational Site
  - Oslo, Norway, 0514
    - GSK Investigational Site
  - Porsgrunn, Norway, N-3922
    - GSK Investigational Site
  - Tønsberg, Norway, 3116
    - GSK Investigational Site
Philippines
- - Manila, Philippines, 1003
    - GSK Investigational Site
  - Quezon City, Philippines, 1101
    - GSK Investigational Site
Poland
- - Gdansk, Poland, 80-402
    - GSK Investigational Site
  - Krakow, Poland, 31-826
    - GSK Investigational Site
  - Krakow, Poland, 31-221
    - GSK Investigational Site
  - Lublin, Poland, 20-950
    - GSK Investigational Site
  - Wroclaw, Poland, 50-043
    - GSK Investigational Site
Portugal
- - Abrantes, Portugal, 2200 Abrantes
    - GSK Investigational Site
  - Lisboa, Portugal, 1069-166
    - GSK Investigational Site
  - Lisboa, Portugal, 1269-098 Lisboa
    - GSK Investigational Site
  - Porto, Portugal, 4099-004
    - GSK Investigational Site
  - Porto, Portugal, 4150-113 PORTO
    - GSK Investigational Site
  - S. Martinho do Bispo, Portugal, 3040-316 Coimbra
    - GSK Investigational Site
Puerto Rico
- - Ponce, Puerto Rico, 00716
    - GSK Investigational Site
  - Santurce, Puerto Rico, 00907
    - GSK Investigational Site
Romania
- - Arad, Romania, 310175
    - GSK Investigational Site
  - Bucharest, Romania, 022328
    - GSK Investigational Site
  - Bucharest, Romania
    - GSK Investigational Site
  - Cluj-Napoca, Romania
    - GSK Investigational Site
  - Iasi, Romania
    - GSK Investigational Site
  - Timisoara, Romania
    - GSK Investigational Site
Russian Federation
- - Moscow, Russian Federation, 105229
    - GSK Investigational Site
  - Moscow, Russian Federation
    - GSK Investigational Site
  - Moscow, Russian Federation, 125367
    - GSK Investigational Site
  - Moscow, Russian Federation, 117 837
    - GSK Investigational Site
  - Moscow, Russian Federation, 109472
    - GSK Investigational Site
  - Moscow, Russian Federation, 125206
    - GSK Investigational Site
  - Rostov-na-Donu, Russian Federation
    - GSK Investigational Site
  - Saint Petersburg, Russian Federation
    - GSK Investigational Site
  - Smolensk, Russian Federation
    - GSK Investigational Site
Slovakia
- - Banska Bystrica, Slovakia, 975 17
    - GSK Investigational Site
  - Bratislava, Slovakia, 813 69
    - GSK Investigational Site
  - Bratislava, Slovakia, 833 05
    - GSK Investigational Site
  - Kosice, Slovakia, 041 66
    - GSK Investigational Site
  - Martin, Slovakia, 036 59
    - GSK Investigational Site
  - Skalica, Slovakia, 909 01
    - GSK Investigational Site
  - Zilina, Slovakia, 010 01
    - GSK Investigational Site
South Africa
- - Cape Town, South Africa, 8001
    - GSK Investigational Site
  - Claremont, South Africa, 7700
    - GSK Investigational Site
  - Somerset West, South Africa, 7130
    - GSK Investigational Site
  - Sunninghill, South Africa, 2157
    - GSK Investigational Site
Spain
- - Alava, Spain, 01004
    - GSK Investigational Site
  - Alcázar de San Juan (Ciudad Real), Spain, 13600
    - GSK Investigational Site
  - Badajoz, Spain, 6080
    - GSK Investigational Site
  - Barcelona, Spain, 08025
    - GSK Investigational Site
  - Barcelona, Spain, 08221
    - GSK Investigational Site
  - Barcelona, Spain, 08022
    - GSK Investigational Site
  - Burgos, Spain, 09005
    - GSK Investigational Site
  - Ciudad Real, Spain, 13005
    - GSK Investigational Site
  - Elche (Alicante), Spain, 03202
    - GSK Investigational Site
  - Gijon, Spain, 33394
    - GSK Investigational Site
  - Guadalajara, Spain, 19002
    - GSK Investigational Site
  - Jerez de la Frontera, Spain, 11407
    - GSK Investigational Site
  - La Coruña, Spain, 15006
    - GSK Investigational Site
  - Langreo (Oviedo), Spain, 33920
    - GSK Investigational Site
  - Las Palmas, Spain, 35020
    - GSK Investigational Site
  - Las Palmas De Gran Canaria, Spain, 35016
    - GSK Investigational Site
  - Madrid, Spain, 28006
    - GSK Investigational Site
  - Madrid, Spain, 28016
    - GSK Investigational Site
  - Malaga, Spain, 29020
    - GSK Investigational Site
  - Manacor (Palma de Mallorca), Spain
    - GSK Investigational Site
  - Marbella, Spain, 29600
    - GSK Investigational Site
  - Mendaro, Guipuzcoa, Spain, 20850
    - GSK Investigational Site
  - Merida, Spain, 6800
    - GSK Investigational Site
  - Murcia, Spain, 30008
    - GSK Investigational Site
  - Palma de Mallorca, Spain, 07014
    - GSK Investigational Site
  - Pamplona, Spain, 31008
    - GSK Investigational Site
  - Pontevedra, Spain, 36071
    - GSK Investigational Site
  - Sabadell (Barcelona), Spain, 08208
    - GSK Investigational Site
  - San Sebastian, Spain, 20012
    - GSK Investigational Site
  - San Sebastián, Spain, 20014
    - GSK Investigational Site
  - Santa Cruz de Tenerife, Spain, 38010
    - GSK Investigational Site
  - Santander, Spain, 38008
    - GSK Investigational Site
  - Santander, Spain
    - GSK Investigational Site
  - Santiago de Compostela, Spain, 15706
    - GSK Investigational Site
  - Tortosa, Spain, 43500
    - GSK Investigational Site
  - Valencia, Spain, 46009
    - GSK Investigational Site
  - Vigo (Pontevedra), Spain, 30211
    - GSK Investigational Site
  - Vigo/Pontevedra, Spain, 36200
    - GSK Investigational Site
  - Vitoria, Spain, 01009
    - GSK Investigational Site
  - Vizcaya, Spain, 48902
    - GSK Investigational Site
Taiwan
- - Kaohsiung, Taiwan, 813
    - GSK Investigational Site
  - Taichung, Taiwan, 404
    - GSK Investigational Site
  - Tainan, Taiwan, 704
    - GSK Investigational Site
  - Taipei, Taiwan, 100
    - GSK Investigational Site
  - Taipei, Taiwan, 112
    - GSK Investigational Site
  - Taipei, Taiwan, 114
    - GSK Investigational Site
  - Taoyuan, Taiwan, 333
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10400
    - GSK Investigational Site
  - Bangkok, Thailand, 10330
    - GSK Investigational Site
  - Bangkok, Thailand, 10700
    - GSK Investigational Site
  - Chiangmai, Thailand, 50200
    - GSK Investigational Site
Tunisia
- - Sousse, Tunisia, 4054
    - GSK Investigational Site
  - Tunis, Tunisia, 1007
    - GSK Investigational Site
  - Tunis, Tunisia, 1008
    - GSK Investigational Site
Turkey
- - Istanbul, Turkey, 34303
    - GSK Investigational Site
  - Izmir, Turkey, 35100
    - GSK Investigational Site
  - Sıhhiye/Ankara, Turkey, 06100
    - GSK Investigational Site
United Kingdom
- - Clydebank, Glasgow, United Kingdom, G81 2DR
    - GSK Investigational Site
  - Dundee, United Kingdom, DD1 9SY
    - GSK Investigational Site
  - Edgbaston, Birmingham, United Kingdom, B15 2SQ
    - GSK Investigational Site
  - Manchester, United Kingdom, M15 6SX
    - GSK Investigational Site
  - Waterloo, Liverpool, United Kingdom, L22 0LG
    - GSK Investigational Site
- Glamorgan
  - Swansea, Glamorgan, United Kingdom, SA4 4NU
    - GSK Investigational Site
- Lancashire
  - Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
    - GSK Investigational Site
- Middlesex
  - Northwood, Middlesex, United Kingdom, HA6 2RN
    - GSK Investigational Site
- Midlothian
  - Edinburgh, Midlothian, United Kingdom, EH4 2XU
    - GSK Investigational Site
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom, OX2 6PD
    - GSK Investigational Site
- Sussex West
  - Chichester, Sussex West, United Kingdom, PO19 4SE
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35209
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35242
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35234
    - GSK Investigational Site
  - Columbiana, Alabama, United States, 35051
    - GSK Investigational Site
  - Hoover, Alabama, United States, 35216
    - GSK Investigational Site
- Alaska
  - Anchorage, Alaska, United States, 99508
    - GSK Investigational Site
- Arizona
  - Phoenix, Arizona, United States, 85032
    - GSK Investigational Site
  - Phoenix, Arizona, Arizona, United States, 86106
    - GSK Investigational Site
- California
  - Beverly Hills, California, United States, 90212
    - GSK Investigational Site
  - Concord, California, United States, 94520
    - GSK Investigational Site
  - Glendora, California, United States, 91741
    - GSK Investigational Site
  - Greenbrae, California, United States, 94904
    - GSK Investigational Site
  - Irvine, California, United States, 92618
    - GSK Investigational Site
  - La Jolla, California, United States, 92093
    - GSK Investigational Site
  - Laguna Woods, California, United States, 92637
    - GSK Investigational Site
  - Los Angelas, California, United States, 90017
    - GSK Investigational Site
  - Los Angeles, California, United States, 90048
    - GSK Investigational Site
  - Modesto, California, United States, 95350
    - GSK Investigational Site
  - Sacramento, California, United States, 95821
    - GSK Investigational Site
  - San Diego, California, United States, 92103
    - GSK Investigational Site
  - San Diego, California, United States, 92108
    - GSK Investigational Site
  - San Diego, California, United States, 91405
    - GSK Investigational Site
  - Torrance, California, United States, 90506
    - GSK Investigational Site
  - Vista, California, United States, 92084
    - GSK Investigational Site
  - los Angeles, California, United States, 90057
    - GSK Investigational Site
- Florida
  - Aventura, Florida, United States, 33180
    - GSK Investigational Site
  - Bay Pines, Florida, United States, 33744
    - GSK Investigational Site
  - Coral Gables, Florida, United States, 33134
    - GSK Investigational Site
  - Daytona Beach, Florida, United States, 32114
    - GSK Investigational Site
  - Lake Worth, Florida, United States, 33461
    - GSK Investigational Site
  - Miami, Florida, United States, 33156
    - GSK Investigational Site
  - New Smyrna Beach, Florida, United States, 32168
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Orange City, Florida, United States, 32763
    - GSK Investigational Site
  - Pensacola, Florida, United States, 32503
    - GSK Investigational Site
  - Pinecrest, Florida, United States, 33156
    - GSK Investigational Site
  - Spring Hill, Florida, United States, 34609
    - GSK Investigational Site
  - St. Augustine, Florida, United States, 32086
    - GSK Investigational Site
  - St. Petersburg, Florida, United States, 33710
    - GSK Investigational Site
  - St. Petersburg, Florida, United States, 33702
    - GSK Investigational Site
  - Stuart, Florida, United States, 34996
    - GSK Investigational Site
  - Tallahassee, Florida, United States, 32308
    - GSK Investigational Site
  - Wellington, Florida, United States, 33414
    - GSK Investigational Site
  - West Palm Beach, Florida, United States, 33407
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - GSK Investigational Site
  - Blue Ridge, Georgia, United States, 30513
    - GSK Investigational Site
  - Calhoun, Georgia, United States, 30701
    - GSK Investigational Site
  - Decatur, Georgia, United States, 30033
    - GSK Investigational Site
  - Marietta, Georgia, United States, 30066
    - GSK Investigational Site
- Idaho
  - Meridian, Idaho, United States, 83642
    - GSK Investigational Site
- Illinois
  - Belleville, Illinois, United States, 62220
    - GSK Investigational Site
  - Peoria, Illinois, United States, 61614
    - GSK Investigational Site
  - Peoria, Illinois, United States, 61602
    - GSK Investigational Site
  - Wheaton, Illinois, United States, 60187
    - GSK Investigational Site
  - Winfield, Illinois, United States, 60190
    - GSK Investigational Site
- Indiana
  - Evansville, Indiana, United States, 47714
    - GSK Investigational Site
  - Jeffersonville, Indiana, United States, 47130
    - GSK Investigational Site
  - Newburgh, Indiana, United States, 47630
    - GSK Investigational Site
  - South Bend, Indiana, United States, 46601
    - GSK Investigational Site
- Iowa
  - Des Moines, Iowa, United States, 50309
    - GSK Investigational Site
- Kansas
  - Wichita, Kansas, United States, 67207
    - GSK Investigational Site
- Kentucky
  - Murray, Kentucky, United States, 42071
    - GSK Investigational Site
- Louisiana
  - Bossier City, Louisiana, United States, 71111
    - GSK Investigational Site
- Maryland
  - Laurel, Maryland, United States, 20724
    - GSK Investigational Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55417
    - GSK Investigational Site
- Mississippi
  - Picayune, Mississippi, United States, 39466
    - GSK Investigational Site
- Missouri
  - Kansas City, Missouri, United States, 64114
    - GSK Investigational Site
- Montana
  - Missoula, Montana, United States, 59802
    - GSK Investigational Site
- Nebraska
  - Omaha, Nebraska, United States, 68102
    - GSK Investigational Site
- Nevada
  - Henderson, Nevada, United States, 89014
    - GSK Investigational Site
- New Jersey
  - Hillsborough, New Jersey, United States, 08844
    - GSK Investigational Site
  - Perth Amboy, New Jersey, United States, 08861
    - GSK Investigational Site
  - Somerville, New Jersey, United States, 08876
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - GSK Investigational Site
- New York
  - Bayshore, New York, United States, 11706
    - GSK Investigational Site
  - Garden City, New York, United States, 11530
    - GSK Investigational Site
  - Great Neck, New York, United States, 11021
    - GSK Investigational Site
  - Lewiston, New York, United States, 14092
    - GSK Investigational Site
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - GSK Investigational Site
  - Cary, North Carolina, United States, 27511
    - GSK Investigational Site
  - Charlotte, North Carolina, United States, 28262
    - GSK Investigational Site
  - Durham, North Carolina, United States, 27710
    - GSK Investigational Site
  - Fayetteville, North Carolina, United States, 28304
    - GSK Investigational Site
  - Greensboro, North Carolina, United States, 27403
    - GSK Investigational Site
  - Salisbury, North Carolina, United States, 28144
    - GSK Investigational Site
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - GSK Investigational Site
- Ohio
  - Bellbrook, Ohio, United States, 45305
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45249
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43214
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43212
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, United States, 97239
    - GSK Investigational Site
- Pennsylvania
  - Fleetwood, Pennsylvania, United States, 19522
    - GSK Investigational Site
- Rhode Island
  - Providence, Rhode Island, United States, 02904
    - GSK Investigational Site
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - GSK Investigational Site
- Texas
  - Athes, Texas, United States, 75751
    - GSK Investigational Site
  - Dallas, Texas, United States, 75230
    - GSK Investigational Site
  - Dallas, Texas, United States, 75390
    - GSK Investigational Site
  - Dallas, Texas, United States, 75234
    - GSK Investigational Site
  - Fort Worth, Texas, United States, 76107
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Houston, Texas, United States, 77024
    - GSK Investigational Site
  - New Brunfels, Texas, United States, 78130
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - Temple, Texas, United States, 76508
    - GSK Investigational Site
  - Texarkana, Texas, United States, 75503
    - GSK Investigational Site
- Utah
  - Salt Lake City, Utah, United States, 84132
    - GSK Investigational Site
- Virginia
  - Alexandria, Virginia, United States, 22304
    - GSK Investigational Site
- Washington
  - Bellevue, Washington, United States, 98004
    - GSK Investigational Site
  - Mountlake Terrace, Washington, United States, 98043
    - GSK Investigational Site
  - Seattle, Washington, United States, 98104
    - GSK Investigational Site
  - Spokane, Washington, United States, 99204
    - GSK Investigational Site
  - Tacoma, Washington, United States, 98405
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

Inclusion criteria:

A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
males, aged ≥50 years
clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
International Prostate Symptom Score (IPSS) ≥12 points at Screening
prostate volume ≥30 cc by transrectal ultrasonography; (TRUS)
total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening
maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
willing and able to give written informed consent and comply with study procedures
fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication
able to swallow and retain oral medication
willing and able to participate in the study for the full 4 years.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

total serum PSA >10.0ng/mL at Screening
history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.

Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.

previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction.
history of AUR within 3 months prior to Screening Visit.
post-void residual volume >250mL (suprapubic ultrasound) at Screening.
any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication).
concurrent use of anabolic steroids
use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study.
use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study.

Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.

use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments.
hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
concurrent use of drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
history of hepatic impairment or abnormal liver function tests at Screening defined as alanine aminotransferase (ALT), aspartate aminotranferase (AST), and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
history of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal or serum creatinine ≥1.5 mg/dL at Screening.
prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
history of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
history of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
history of unsuccessful treatment with finasteride or dutasteride
history or current evidence of drug or alcohol abuse within the previous 12 months.
participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding the Screening Visit and/or during the course of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dutasteride dutasteride 0.5mg once daily	Drug: dutasteride 0.5mg once daily for 4 years combination or single agent
Experimental: Combo Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily	Drug: dutasteride 0.5mg once daily for 4 years combination or single agent Drug: tamsulosin 0.4mg once daily for 4 years combination agent or single agent Other Names: dutasteride tamsulosin
Active Comparator: tamsulosin tamsulosin 0.4mg once daily	Drug: tamsulosin 0.4mg once daily for 4 years combination agent or single agent Other Names: dutasteride tamsulosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. Time Frame: Years 1, 2, 3, and 4	A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.	Years 1, 2, 3, and 4
Number of Participants With AUR or BPH-related Surgery Time Frame: Baseline (Day 1) through Year 4	A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.	Baseline (Day 1) through Year 4

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 24, 2004

First Submitted That Met QC Criteria

August 25, 2004

First Posted (Estimate)

August 26, 2004

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ARI40005

Plan for Individual participant data (IPD)

Study Data/Documents

Annotated Case Report Form
Information identifier: ARI40005

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: ARI40005

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: ARI40005

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: ARI40005

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: ARI40005

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: ARI40005

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: ARI40005

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 Time Frame: Years 1, 2, 3, and 4	The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.	Years 1, 2, 3, and 4
The Number of Participants With Each of the Five Components of BPH Clinical Progression Time Frame: Baseline (Day 1) to Year 4	The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.	Baseline (Day 1) to Year 4
Number of Events of Symptom Deterioration at the Indicated Time Periods Time Frame: Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)	The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).	Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)
Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria Time Frame: Baseline (Day 1) through Year 4	A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.	Baseline (Day 1) through Year 4
Number of Participants With an Event of Post-baseline BPH-related Hematospermia Time Frame: Baseline (Day 1) through Year 4	A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.	Baseline (Day 1) through Year 4
Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 Time Frame: Baseline and Months 12, 24, 36, and 48	The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.	Baseline and Months 12, 24, 36, and 48
Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 Time Frame: Baseline and Months 12, 24, 36, and 48	Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.	Baseline and Months 12, 24, 36, and 48
Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 Time Frame: Baseline and Months 12, 24, 36, and 48	Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.	Baseline and Months 12, 24, 36, and 48
Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 Time Frame: Baseline and Months 12, 24, 36, and 48	Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.	Baseline and Months 12, 24, 36, and 48
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit Time Frame: Every 3 months from Month 3 to Month 48	At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit?" If the answer to the question was "yes," the number of visits was recorded.	Every 3 months from Month 3 to Month 48
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?. Time Frame: Every 3 months from Month 3 to Month 48	At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?". If the answer to the question was "yes," the number of Yes responses was recorded.	Every 3 months from Month 3 to Month 48
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit Time Frame: Every 3 months from Month 3 to Month 48	At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of visits was recorded.	Every 3 months from Month 3 to Month 48
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?" Time Frame: Every 3 months from Month 3 to Month 48	At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of Yes responses was recorded.	Every 3 months from Month 3 to Month 48
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) Time Frame: Every 3 months from Month 3 to Month 48	At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?". If the answer to the question was "yes," the number of visits was recorded.	Every 3 months from Month 3 to Month 48
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) Time Frame: Every 3 months from Month 3 to Month 48	At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?". If the answer to the question was "yes," the number of visits was recorded.	Every 3 months from Month 3 to Month 48
Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 Time Frame: Baseline and Months 12, 24, 36, and 48	The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.	Baseline and Months 12, 24, 36, and 48
Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 Time Frame: Baseline and Months 12, 24, 36, 48	The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.	Baseline and Months 12, 24, 36, 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has control of your urinary problems changed?".	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on control of your urinary problems?" Satisfact., satisfaction.	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has the strength of your urinary stream changed?".	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on the strength of your urinary stream?". Satisfact., satisfaction.	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has your pain prior to urinating changed?".	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain prior to urinating?". Satisfact., satisfaction.	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has your pain during urination changed?".	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain during urination?". Satisfact., satisfaction.	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?".	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?". Satisfact., satisfaction.	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Overall, how satisfied are you with the study medication and it's effect on your urinary problems?". Satisfact., satisfaction.	Baseline and Months 12, 24, 36, and 48
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) Time Frame: Baseline and Months 12, 24, 36, and 48	This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Would you ask your doctor for the medication you received in this study?".	Baseline and Months 12, 24, 36, and 48

Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

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