- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01018511
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (Neptune)
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
Study Overview
Status
Intervention / Treatment
- Drug: Placebo tamsulosin hydrochloride OCAS 0.4 mg
- Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg
- Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
- Drug: tamsulosin hydrochloride OCAS 0.4 mg
- Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
- Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Innsbruck, Austria, 6020
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Salzburg, Austria, 5020
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Vienna, Austria, 1090
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Minsk, Belarus, 220036
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Minsk, Belarus, 220119
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Minsk, Belarus, 220114
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Antwerp, Belgium, 2020
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Antwerp, Belgium, 2030
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Assebroek, Belgium, 8310
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Brussels, Belgium, 1090
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Brussels, Belgium, 1200
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Brussels, Belgium, 1070
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Edegem, Belgium, 2650
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Gent, Belgium, 9000
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Liege 1, Belgium, 4000
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Sint-Truiden, Belgium, 3800
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Turnhout, Belgium, 2300
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Hradec Kralove, Czech Republic, 500 02
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Ostrava, Czech Republic, 700 30
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Plzen, Czech Republic, 301 24
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Prague, Czech Republic, 180 81
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Roudnice nad Labem, Czech Republic, 413 01
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Uherske Hradiste, Czech Republic, 686 08
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Usti nad Labem, Czech Republic, 40001
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Zdar nad Sazavou, Czech Republic, 591 01
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Aix en Provence, France, 13616
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Angers, France, 49033
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Bordeaux Cedex, France, 33076
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Colmar Cedex, France, 68024
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Dijon, France, 21000
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Dijon, France, 21079
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Lyon Cedex 3, France, 69437
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Montlucon, France, 03100
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Orleans Cedex 2, France, 45067
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Paris, France, 75010
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Paris Cedex 10, France, 75020
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Paris Cedex 14, France, 75679
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Pierre Benite, France, 69495
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Rennes, France, 35033
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Tours Cedex, France, 37044
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Bad Ems, Germany, 56130
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Bautzen, Germany, 02625
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Frankfurt, Germany, 65933
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Hagenow, Germany, 19230
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Halle Saale, Germany, 06132
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Hamburg, Germany, 20253
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Henningsdorf, Germany, 16761
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Hettstedt, Germany, 06333
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Koblenz, Germany, 56068
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Leipzig, Germany, 04105
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Leipzig, Germany, 04109
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Lutherstadt Eisleben, Germany, 06295
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Neustadt in Sachsen, Germany, 01844
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Uetersen, Germany, 25436
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Budapest, Hungary, 1204
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Kormend, Hungary, 9900
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Nyiregyhaza, Hungary, 4400
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Sopron, Hungary, 9400
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Szekszard, Hungary, 7100
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Szentes, Hungary, 6601
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Tatabanya, Hungary, 2800
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Avellino, Italy, 83100
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Bari, Italy, 70124
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Bergamo, Italy, 24125
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Catania, Italy, 95124
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Catanzaro, Italy, 88100
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Florence, Italy, 50139
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Palermo, Italy, 90146
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Treviglio, Italy, 24047
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Turin, Italy, 10154
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Amsterdam, Netherlands, 1100 AD
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Apeldoorn, Netherlands, 7334 DZ
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Doetinchem, Netherlands, 7009 BL
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Eindhoven, Netherlands, 5623 EJ
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Etten-Leur, Netherlands, 4872 LA
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Maastricht, Netherlands, 6229 HX
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Sneek, Netherlands, 8600 BA
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Sneek, Netherlands, 8601 ZK
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Tilburg, Netherlands, 5022 GC
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Winterswijk, Netherlands, 7101 BN
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Bielsko Biala, Poland, 43-300
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Bydgoszcz, Poland, 85-094
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Krakow, Poland, 31-530
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Pulawy, Poland, 24-100
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Warsaw, Poland, 02-005
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Wiecbork, Poland, 89-410
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Moscow, Russian Federation, 125206
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Moscow, Russian Federation, 111020
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Moscow, Russian Federation, 111123
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Moscow, Russian Federation, 119435
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St. Petersburg, Russian Federation, 197089
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St. Petersburg, Russian Federation, 198013
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Nitra, Slovakia, 949 01
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Piestany, Slovakia, 921 01
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Presov, Slovakia, 080 01
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Skalica, Slovakia, 909 82
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Trencin, Slovakia, 911 01
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Zilina, Slovakia
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Birmingham, United Kingdom, B15 2SQ
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Bristol, United Kingdom, BS10 5NB
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Bristol, United Kingdom, BS2 8HW
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Cardiff, United Kingdom, CF14 5GJ
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Chorley, United Kingdom, PR7 7NA
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Glasgow, United Kingdom, G20 0XA
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Glasgow, United Kingdom, G81 2DR
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Liverpool, United Kingdom, L22 0LG
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Manchester, United Kingdom, M15 6SX
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Northwood, United Kingdom, HA6 2RN
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Nottingham, United Kingdom, NG5 1PB
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Plymouth, United Kingdom, PL6 8DH
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Reading, United Kingdom, RG2 0TG
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Reading, United Kingdom, RG1 5AN
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Reading, United Kingdom, RG2 7AG
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Sheffield, United Kingdom, S10 2JF
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Taunton, United Kingdom, TA1 5DA
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Torquay, United Kingdom, TQ2 7AA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months
- A total International Prostate Symptom Score (IPSS) of ≥13
- A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
- A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)
Exclusion Criteria:
- Any significant Post Void Residual volume (>150 mL)
- A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound
- Evidence of a symptomatic urinary tract infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Participants received 3 tablets once a day for 12 weeks.
Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
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tablet
tablet
tablet
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Active Comparator: TOCAS 0.4 mg
Participants received 3 tablets once a day for 12 weeks.
Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
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tablet
tablet
tablet
Other Names:
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Experimental: FDC 0.4 mg/6 mg
Participants received 3 tablets once a day for 12 weeks.
Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
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tablet
tablet
tablet
Other Names:
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Experimental: FDC 0.4 mg/9 mg
Participants received 3 tablets once a day for 12 weeks.
Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
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tablet
tablet
tablet
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline to End of Treatment in Total International Prostate Symptom Score
Time Frame: Baseline and Week 12
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The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:
Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic). |
Baseline and Week 12
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Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
Time Frame: Baseline and Week 12
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The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:
TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency. |
Baseline and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Time Frame: Baseline and Week 12
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A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
Time Frame: Baseline and Week 12
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A micturition is any voluntary urination, excluding episodes of incontinence only.
The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
Time Frame: Baseline and Week 12
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A micturition is any voluntary urination, excluding episodes of incontinence only.
The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
Time Frame: Baseline and Week 12
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An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain.
The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Time Frame: Baseline and Week 12
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An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency.
The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Time Frame: Baseline and Week 12
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An incontinence episode is defined as an episode with any involuntary loss of urine.
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
Time Frame: Baseline and Week 12
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A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake).
The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
Time Frame: Baseline and Week 12
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The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
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Baseline and Week 12
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Change From Baseline to End of Treatment in IPSS Voiding Score
Time Frame: Baseline and Week 12
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The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions.
Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
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Baseline and Week 12
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Change From Baseline to End of Treatment in IPSS Storage Score
Time Frame: Baseline and Week 12
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The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms.
Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
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Baseline and Week 12
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Change From Baseline to End of Treatment in IPSS QoL Score
Time Frame: Baseline and Week 12
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The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life.
The answers ranged from 0 to 6 (delighted to terrible).
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Baseline and Week 12
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Change From Baseline to End of Treatment in Individual IPSS Scores
Time Frame: Baseline and Week 12
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The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:
Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. |
Baseline and Week 12
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Change From Baseline to End of Treatment in Symptom Bother Score
Time Frame: Baseline and Week 12
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The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL).
The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.
The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity.
A negative change from baseline indicates an improvement.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score
Time Frame: Baseline and Week 12
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The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. |
Baseline and Week 12
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Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score
Time Frame: Baseline and Week 12
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The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. |
Baseline and Week 12
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Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score
Time Frame: Baseline and Week 12
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The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. |
Baseline and Week 12
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Change From Baseline to End of Treatment in HRQoL Subscale: Social Score
Time Frame: Baseline and Week 12
|
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. |
Baseline and Week 12
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Change From Baseline to End of Treatment in HRQoL Subscale: Total Score
Time Frame: Baseline and Week 12
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The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. |
Baseline and Week 12
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Percentage of Participants Who Were OAB-q Responders at End of Treatment
Time Frame: Week 12 (end of treatment)
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A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
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Week 12 (end of treatment)
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Change From Baseline to End of Treatment in EQ-5D Mobility Score
Time Frame: Baseline and Week 12
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The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed). |
Baseline and Week 12
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Change From Baseline to End of Treatment in EQ-5D Self-care Score
Time Frame: Baseline and Week 12
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The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress). |
Baseline and Week 12
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Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
Time Frame: Baseline and Week 12
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The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities). |
Baseline and Week 12
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Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
Time Frame: Baseline and Week 12
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The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain). |
Baseline and Week 12
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Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
Time Frame: Baseline and Week 12
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The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious). |
Baseline and Week 12
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Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Time Frame: Baseline and Week 12
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Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire.
The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
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Baseline and Week 12
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Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms
Time Frame: Baseline and Week 12
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The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study.
The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
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Baseline and Week 12
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Patient Global Impression Scale at End of Treatment: General Health
Time Frame: Baseline and Week 12
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The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study.
The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
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Baseline and Week 12
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Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms
Time Frame: Baseline and Week 12
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The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study.
The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
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Baseline and Week 12
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Number of Participants With Adverse Events (AEs)
Time Frame: From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)
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Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant.
A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.
AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug.
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.
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From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)
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Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
Time Frame: Baseline and Week 12
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PVR volume is the volume of urine retained after voiding.
PVR volume was assessed by ultrasonography or bladder scan.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Time Frame: Baseline and Week 12
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Qmax during a micturition (urination) was recorded using uroflowmetry.
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Baseline and Week 12
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Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Time Frame: Baseline and Week 12
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Qmean during a micturition (urination) was recorded using uroflowmetry.
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Baseline and Week 12
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Apparent Clearance (CL/F) of Tamsulosin
Time Frame: Week 4, Week 8 and Week 12
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Week 4, Week 8 and Week 12
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Maximum Concentration at Steady State (Cmaxss) of Tamsulosin
Time Frame: Week 4, Week 8 and Week 12
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Week 4, Week 8 and Week 12
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Minimum Concentration at Steady State (Cminss) of Tamsulosin
Time Frame: Week 4, Week 8 and Week 12
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Week 4, Week 8 and Week 12
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Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin
Time Frame: Week 4, Week 8 and Week 12
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Week 4, Week 8 and Week 12
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Area Under the Curve at Steady State (AUCss) of Tamsulosin
Time Frame: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
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Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
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CL/F of Solifenacin
Time Frame: Week 4, Week 8 and Week 12
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Week 4, Week 8 and Week 12
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Cmaxss of Solifenacin
Time Frame: Week 4, Week 8 and Week 12
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Week 4, Week 8 and Week 12
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Cminss of Solifenacin
Time Frame: Week 4, Week 8 and Week 12
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Week 4, Week 8 and Week 12
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Tmaxss of Solifenacin
Time Frame: Week 4, Week 8 and Week 12
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Week 4, Week 8 and Week 12
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AUCss of Solifenacin
Time Frame: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
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Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Urological Manifestations
- Prostatic Diseases
- Prostatic Hyperplasia
- Hyperplasia
- Lower Urinary Tract Symptoms
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tamsulosin
- Solifenacin Succinate
Other Study ID Numbers
- 905-CL-055
- 2008-001211-37 (Other Identifier: EudraCT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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Baylor Research InstituteForte MedicalCompletedLower Urinary Tract Symptoms | Lower Urinary Tract InfectionUnited States
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Jagiellonian UniversityPiotr ChlostaCompletedTo Evaluate Lower Urinary Tract Symptoms (LUTS) in PolandPoland
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Boston Scientific CorporationTerminatedBPH | BPH With Urinary Obstruction | BPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsUnited States, Australia
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Benaroya Research InstituteVirginia Mason Hospital/Medical CenterUnknownPain | BPH With Urinary Obstruction | BPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsUnited States
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San Carlo di Nancy HospitalLampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)CompletedBPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsItaly
Clinical Trials on Placebo tamsulosin hydrochloride OCAS 0.4 mg
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ChaingMai UniversityUnknown
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Astellas Pharma Europe B.V.CompletedLower Urinary Tract Symptoms | Benign Prostatic HyperplasiaBelgium, Italy, France, Austria, United Kingdom, Netherlands, Poland, Slovakia, Belarus, Germany, Czechia
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Kocatepe UniversityCompletedBenign Prostatic Hyperplasia | Choroid Disease | Pupil Anomaly
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CHU de Quebec-Universite LavalRecruiting
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Azienda Ospedaliero Universitaria Maggiore della...RecruitingLower Urinary Tract Symptoms | Benign Prostatic Hyperplasia | Urinary ObstructionItaly
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Kwang Dong Pharmaceutical co., ltd.Completed
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Mansoura UniversityActive, not recruitingOveractive Bladder | Benign Prostatic HyperplasiaEgypt
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GlaxoSmithKlineCompleted
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Assistance Publique - Hôpitaux de ParisTerminated
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Pontificia Universidad Catolica de ChileTerminatedUrolithiasis | Ureteral Calculi | UreterolithiasisChile