Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension

March 28, 2014 updated by: Forest Laboratories

A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed Dose Combination in Patients With Stage 1 or 2 Essential Hypertension

To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4161

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

United States
- Alabama
  - Birmingham, Alabama, United States, 35216
    - Forest Investigative Site 1750
  - Birmingham, Alabama, United States, 35235
    - Forest Investigative Site 1038
  - Birmingham, Alabama, United States, 35235
    - Forest Investigative Site 1308
  - Birmingham, Alabama, United States, 35242
    - Forest Investigative Site 1192
  - Birmingham, Alabama, United States, 35294
    - Forest Investigative Site 1005
  - Foley, Alabama, United States, 36535
    - Forest Investigative Site 1047
  - Gulf Shores, Alabama, United States, 36542
    - Forest Investigative Site 1717
  - Mobile, Alabama, United States, 36617
    - Forest Investigative Site 1056
  - Muscle Shoals, Alabama, United States, 35662
    - Forest Investigative Site 1719
- Arizona
  - Glendale, Arizona, United States, 85308
    - Forest Investigative Site 1145
  - Goodyear, Arizona, United States, 85395
    - Forest Investigative Site 1703
  - Mesa, Arizona, United States, 85202
    - Forest Investigative Site 1757
  - Phoenix, Arizona, United States, 85015
    - Forest Investigative Site 1170
  - Phoenix, Arizona, United States, 85018
    - Forest Investigative Site 1238
  - Phoenix, Arizona, United States, 85020
    - Forest Investigative Site 1204
  - Phoenix, Arizona, United States, 85020
    - Forest Investigative Site 1755
  - Phoenix, Arizona, United States, 85032
    - Forest Investigative Site 1259
  - Phoenix, Arizona, United States, 85050
    - Forest Investigative Site 1001
  - Scottsdale, Arizona, United States, 85251
    - Forest Investigative Site 1078
  - Tempe, Arizona, United States, 85282
    - Forest Investigative Site 1225
  - Tempe, Arizona, United States, 85282
    - Forest Investigative Site 1712
  - Tempe, Arizona, United States, 85283
    - Forest Investigative Site 1089
  - Tucson, Arizona, United States, 85704
    - Forest Investigative Site 1065
  - Tucson, Arizona, United States, 85712
    - Forest Investigative Site 1340
  - Tucson, Arizona, United States, 85745
    - Forest Investigative Site 1331
- Arkansas
  - Little Rock, Arkansas, United States, 72204
    - Forest Investigative Site 1290
  - Little Rock, Arkansas, United States, 72211
    - Forest Investigative Site 1138
  - Pine Bluff, Arkansas, United States, 71603
    - Forest Investigative Site 1371
  - Searcy, Arkansas, United States, 72143
    - Forest Investigative Site 1220
- California
  - Buena Park, California, United States, 90620
    - Forest Investigative Site 1063
  - Burbank, California, United States, 91505
    - Forest Investigative Site 1743
  - Carmichael, California, United States, 95608
    - Forest Investigative Site 1006
  - Chino, California, United States, 91710
    - Forest Investigative Site 1384
  - Chula Vista, California, United States, 91911
    - Forest Investigative Site 1190
  - Costa Mesa, California, United States, 92626
    - Forest Investigative Site 1178
  - Diamond Bar, California, United States, 91765
    - Forest Investigative Site 1043
  - Encinitas, California, United States, 92024
    - Forest Investigative Site 1362
  - Fresno, California, United States, 93721
    - Forest Investigative Site 1144
  - Fresno, California, United States, 93726
    - Forest Investigative Site 1095
  - Garden Grove, California, United States, 92844
    - Forest Investigative Site 1710
  - Greenbrae, California, United States, 94904
    - Forest Investigative Site 1022
  - Huntington Beach, California, United States, 92647
    - Forest Investigative Site 1370
  - Huntington Park, California, United States, 90255
    - Forest Investigative Site 1704
  - Huntington Park, California, United States, 90255
    - Forest Investigative Site 1725
  - La Mesa, California, United States, 91942
    - Forest Investigative Site 1742
  - Lomita, California, United States, 90717
    - Forest Investigative Site 1381
  - Long Beach, California, United States, 90806
    - Forest Investigative Site 1706
  - Los Angelas, California, United States, 90057
    - Forest Investigative Site 1248
  - Los Angelas, California, United States, 90057
    - Forest Investigative Site 1785
  - Los Angeles, California, United States, 90017
    - Forest Investigative Site 1029
  - Los Angeles, California, United States, 90017
    - Forest Investigative Site 1361
  - Los Angeles, California, United States, 90036
    - Forest Investigative Site 1102
  - Mission Hills, California, United States, 91345
    - Forest Investigative Site 1054
  - Moreno Valley, California, United States, 92553
    - Forest Investigative Site 1386
  - Newport Beach, California, United States, 92663
    - Forest Investigative Site 1756
  - Northridge, California, United States, 91325
    - Forest Investigative Site 1181
  - Orange, California, United States, 92868
    - Forest Investigative Site 1212
  - Palm Springs, California, United States, 92262
    - Forest Investigative Site 1101
  - Paramount, California, United States, 90723
    - Forest Investigative Site 1014
  - Pismo Beach, California, United States, 93449
    - Forest Investigative Site 1150
  - Riverside, California, United States, 92506
    - Forest Investigative Site 1009
  - Roseville, California, United States, 95661
    - Forest Investigative Site 1241
  - Sacramento, California, United States, 95816
    - Forest Investigative Site 1046
  - Sacramento, California, United States, 95821
    - Forest Investigative Site 1193
  - Sacramento, California, United States, 95823
    - Forest Investigative Site 1296
  - Sacramento, California, United States, 95825
    - Forest Investigative Site 1716
  - San Bernardino, California, United States, 92404
    - Forest Investigative Site 1096
  - San Diego, California, United States, 92056
    - Forest Investigative Site 1189
  - San Diego, California, United States, 92103
    - Forest Investigative Site 1279
  - San Diego, California, United States, 92114
    - Forest Investigative Site 1354
  - San Diego, California, United States, 92117
    - Forest Investigative Site 1724
  - San Diego, California, United States, 92120
    - Forest Investigative Site 1106
  - San Francisco, California, United States, 94115
    - Forest Investigative Site 1027
  - San Marino, California, United States, 91108
    - Forest Investigative Site 1017
  - San Ramon, California, United States, 94583
    - Forest Investigative Site 1158
  - Santa Ana, California, United States, 92705
    - Forest Investigative Site 1318
  - Spring Valley, California, United States, 91978
    - Forest Investigative Site 1239
  - Stockton, California, United States, 95204
    - Forest Investigative Site 1792
  - Sylmar, California, United States, 91342
    - Forest Investigative Site 1301
  - Temecula, California, United States, 92591
    - Forest Investigative Site 1066
  - Tustin, California, United States, 92781
    - Forest Investigative Site 1729
  - Westlake Village, California, United States, 91361
    - Forest Investigative Site 1783
- Colorado
  - Colorado Springs, Colorado, United States, 80904
    - Forest Investigative Site 1162
  - Denver, Colorado, United States, 80209
    - Forest Investigative Site 1270
  - Denver, Colorado, United States, 80220
    - Forest Investigative Site 1711
  - Northglenn, Colorado, United States, 80234
    - Forest Investigative Site 1013
  - Thornton, Colorado, United States, 80233
    - Forest Investigative Site 1400
- Connecticut
  - Bridgeport, Connecticut, United States, 06610
    - Forest Investigative Site 1324
  - Cromwell, Connecticut, United States, 06416
    - Forest Investigative Site 1045
  - Stamford, Connecticut, United States, 06905
    - Forest Investigative Site 1059
  - Waterbury, Connecticut, United States, 06708
    - Forest Investigative Site 1072
- Florida
  - Boca Raton, Florida, United States, 33432
    - Forest Investigative Site 1159
  - Bradenton, Florida, United States, 34208
    - Forest Investigative Site 1007
  - Brandon, Florida, United States, 33511
    - Forest Investigative Site 1042
  - Brooksville, Florida, United States, 34601
    - Forest Investigative Site 1702
  - Clearwater, Florida, United States, 33756
    - Forest Investigative Site 1764
  - Coral Gables, Florida, United States, 33134
    - Forest Investigative Site 1182
  - Coral Gables, Florida, United States, 33134
    - Forest Investigative Site 1249
  - Cutler Bay, Florida, United States, 33189
    - Forest Investigative Site 1221
  - Daytona Beach, Florida, United States, 32117
    - Forest Investigative Site 1793
  - DeFuniak Springs, Florida, United States, 32435
    - Forest Investigative Site 1100
  - Deerfield Beach, Florida, United States, 33441
    - Forest Investigative Site 1266
  - Deland, Florida, United States, 32720
    - Forest Investigative Site 1734
  - Doral, Florida, United States, 33166
    - Forest Investigative Site 1775
  - Doral, Florida, United States, 33172
    - Forest Investigative Site 1378
  - Edgewater, Florida, United States, 32132
    - Forest Investigative Site 1237
  - Fort Lauderdale, Florida, United States, 33306
    - Forest Investigative Site 1068
  - Fort Lauderdale, Florida, United States, 33319
    - Forest Investigative Site 1330
  - Ft. Lauderdale, Florida, United States, 33308
    - Forest Investigative Site 1026
  - Gainsville, Florida, United States, 32605
    - Forest Investigative Site 1794
  - Hallandale Beach, Florida, United States, 33009
    - Forest Investigative Site 1261
  - Hialeah, Florida, United States, 33012
    - Forest Investigative Site 1240
  - Hialeah, Florida, United States, 33012
    - Forest Investigative Site 1260
  - Hollywood, Florida, United States, 33021
    - Forest Investigative Site 1155
  - Jacksonville, Florida, United States, 32216
    - Forest Investigative Site 1233
  - Jacksonville, Florida, United States, 32216
    - Forest Investigative Site 1253
  - Jacksonville, Florida, United States, 32216
    - Forest Investigative Site 1264
  - Jacksonville, Florida, United States, 32223
    - Forest Investigative Site 1256
  - Jupiter, Florida, United States, 33458
    - Forest Investigative Site 1077
  - Kissimmee, Florida, United States, 34741
    - Forest Investigative Site 1041
  - Kissimmee, Florida, United States, 34741
    - Forest Investigative Site 1399
  - Miami, Florida, United States, 33014
    - Forest Investigative Site 1784
  - Miami, Florida, United States, 33125
    - Forest Investigative Site 1364
  - Miami, Florida, United States, 33135
    - Forest Investigative Site 1206
  - Miami, Florida, United States, 33136
    - Forest Investigative Site 1397
  - Miami, Florida, United States, 33143
    - Forest Investigative Site 1180
  - Miami, Florida, United States, 33144
    - Forest Investigative Site 1396
  - Miami, Florida, United States, 33155
    - Forest Investigative Site 1154
  - Miami, Florida, United States, 33169
    - Forest Investigative Site 1788
  - Miami, Florida, United States, 33183
    - Forest Investigative Site 1223
  - Miami, Florida, United States, 33185
    - Forest Investigative Site 1707
  - Miami, Florida, United States, 33186
    - Forest Investigative Site 1282
  - Miami Springs, Florida, United States, 33166
    - Forest Investigative Site 1297
  - New Port Richey, Florida, United States, 34652
    - Forest Investigative Site 1708
  - North Miami Beach, Florida, United States, 33162
    - Forest Investigative Site 1176
  - Oldsmar, Florida, United States, 34677
    - Forest Investigative Site 1284
  - Opa-Locka, Florida, United States, 33054
    - Forest Investigative Site 1232
  - Orlando, Florida, United States, 32806
    - Forest Investigative Site 1802
  - Orlando, Florida, United States, 32811
    - Forest Investigative Site 1049
  - Orlando, Florida, United States, 32822
    - Forest Investigative Site 1235
  - Ormond Beach, Florida, United States, 32174
    - Forest Investigative Site 1741
  - Oviedo, Florida, United States, 32765
    - Forest Investigative Site 1003
  - Palm Harbor, Florida, United States, 34684
    - Forest Investigative Site 1369
  - Pembroke Pines, Florida, United States, 33024
    - Forest Investigative Site 1079
  - Pembroke Pines, Florida, United States, 33026
    - Forest Investigative Site 1053
  - Pembroke Pines, Florida, United States, 33028
    - Forest Investigative Site 1055
  - Pembroke Pines, Florida, United States, 33028
    - Forest Investigative Site 1161
  - Pembroke Pines, Florida, United States, 33028
    - Forest Investigative Site 1166
  - Pembroke Pines, Florida, United States, 33028
    - Forest Investigative Site 1224
  - Pembroke Pines, Florida, United States, 33029
    - Forest Investigative Site 1075
  - Pinellas Park, Florida, United States, 33782
    - Forest Investigative Site 1368
  - Plant City, Florida, United States, 33563
    - Forest Investigative Site 1023
  - Ponte Vedra, Florida, United States, 32081
    - Forest Investigative Site 1737
  - Port Orange, Florida, United States, 32127
    - Forest Investigative Site 1749
  - South Miami, Florida, United States, 33143
    - Forest Investigative Site 1739
  - St. Cloud, Florida, United States, 34769
    - Forest Investigative Site 1069
  - St. Cloud, Florida, United States, 34769
    - Forest Investigative Site 1315
  - St. Petersburg, Florida, United States, 33701
    - Forest Investigative Site 1243
  - St. Petersburg, Florida, United States, 33709
    - Forest Investigative Site 1723
  - St. Petersburg, Florida, United States, 33716
    - Forest Investigative Site 1730
  - Tamarack, Florida, United States, 33321
    - Forest Investigative Site 1076
  - Tampa, Florida, United States, 33606
    - Forest Investigative Site 1032
  - Tampa, Florida, United States, 33607
    - Forest Investigative Site 1302
  - Winter Haven, Florida, United States, 33880
    - Forest Investigative Site 1120
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Forest Investigative Site 1281
  - Atlanta, Georgia, United States, 30338
    - Forest Investigative Site 1745
  - Blue Ridge, Georgia, United States, 30513
    - Forest Investigative Site 1080
  - Lilburn, Georgia, United States, 30047
    - Forest Investigative Site 1236
  - Marietta, Georgia, United States, 30060
    - Forest Investigative Site 1389
  - Marietta, Georgia, United States, 30066
    - Forest Investigative Site 1002
  - Oakwood, Georgia, United States, 30566
    - Forest Investigative Site 1390
  - Sandy Springs, Georgia, United States, 30328
    - Forest Investigative Site 1333
  - Savannah, Georgia, United States, 31419
    - Forest Investigative Site 1332
  - Snellville, Georgia, United States, 30039
    - Forest Investigative Site 1252
  - Snellville, Georgia, United States, 30078
    - Forest Investigative Site 1353
  - Stockbridge, Georgia, United States, 30281
    - Forest Investigative Site 1740
  - Woodstock, Georgia, United States, 30189
    - Forest Investigative Site 1173
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - Forest Investigative Site 1018
- Idaho
  - Blackfoot, Idaho, United States, 83221
    - Forest Investigative Site 1398
  - Boise, Idaho, United States, 83704
    - Forest Investigative Site 1727
  - Hayden Lake, Idaho, United States, 83835
    - Forest Investigative Site 1387
  - Meridian, Idaho, United States, 83646
    - Forest Investigative Site 1004
  - Nampa, Idaho, United States, 83686
    - Forest Investigative Site 1039
- Illinois
  - Addison, Illinois, United States, 60101
    - Forest Investigative Site 1790
  - Arlington Heights, Illinois, United States, 60004
    - Forest Investigative Site 1093
  - Chicago, Illinois, United States, 60607
    - Forest Investigative Site 1747
  - Chicago, Illinois, United States, 60611
    - Forest Investigative Site 1071
  - Chicago, Illinois, United States, 60616
    - Forest Investigative Site 1752
  - Hazel Crest, Illinois, United States, 60429
    - Forest Investigative Site 1403
  - Morton, Illinois, United States, 61550
    - Forest Investigative Site 1126
  - O'Fallon, Illinois, United States, 62269
    - Forest Investigative Site 1283
- Indiana
  - Evansville, Indiana, United States, 47710
    - Forest Investigative Site 1091
  - Evansville, Indiana, United States, 47712
    - Forest Investigative Site 1103
  - Muncie, Indiana, United States, 47304
    - Forest Investigative Site 1147
- Kansas
  - Augusta, Kansas, United States, 67010
    - Forest Investigative Site 1107
  - Hutchinson, Kansas, United States, 67502
    - Forest Investigative Site 1345
  - Lenexa, Kansas, United States, 66219
    - Forest Investigative Site 1805
  - Mission, Kansas, United States, 66202
    - Forest Investigative Site 1255
  - Newton, Kansas, United States, 67114
    - Forest Investigative Site 1092
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Forest Investigative Site 1801
  - Lexington, Kentucky, United States, 40509
    - Forest Investigative Site 1366
  - Louisville, Kentucky, United States, 40213
    - Forest Investigative Site 1770
  - Madisonville, Kentucky, United States, 42431
    - Forest Investigative Site 1177
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Forest Investigative Site 1251
  - Covington, Louisiana, United States, 70433
    - Forest Investigative Site 1215
  - Eunice, Louisiana, United States, 70535
    - Forest Investigative Site 1274
  - Metairie, Louisiana, United States, 70006
    - Forest Investigative Site 1323
  - Metairie, Louisiana, United States, 77002
    - Forest Investigative Site 1795
  - New Orleans, Louisiana, United States, 70115
    - Forest Investigative Site 1285
  - New Orleans, Louisiana, United States, 70119
    - Forest Investigative Site 1779
- Maine
  - Auburn, Maine, United States, 04210
    - Forest Investigative Site 1769
- Maryland
  - Baltimore, Maryland, United States, 21209
    - Forest Investigative Site 1125
  - Baltimore, Maryland, United States, 21236
    - Forest Investigative Site 1263
  - Lutherville, Maryland, United States, 21093
    - Forest Investigative Site 1128
- Massachusetts
  - Haverhill, Massachusetts, United States, 01830
    - Forest Investigative Site 1726
  - Hyannis, Massachusetts, United States, 02601
    - Forest Investigative Site 1061
  - North Dartmouth, Massachusetts, United States, 02747
    - Forest Investigative Site 1728
  - Watertown, Massachusetts, United States, 02472-3930
    - Forest Investigative Site 1356
- Michigan
  - Chelsea, Michigan, United States, 48118
    - Forest Investigative Site 1336
  - Flint, Michigan, United States, 48504
    - Forest Investigative Site 1097
  - Kalamazoo, Michigan, United States, 49009
    - Forest Investigative Site 1165
  - Stevensville, Michigan, United States, 49127
    - Forest Investigative Site 1337
  - Traverse City, Michigan, United States, 49684
    - Forest Investigative Site 1768
  - Troy, Michigan, United States, 48085
    - Forest Investigative Site 1064
- Mississippi
  - Belzoni, Mississippi, United States, 39038
    - Forest Investigative Site 1025
  - Jackson, Mississippi, United States, 39289-1214
    - Forest Investigative Site 1057
  - Olive Branch, Mississippi, United States, 38654
    - Forest Investigative Site 1034
  - Picayune, Mississippi, United States, 39466
    - Forest Investigative Site 1271
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Forest Investigative Site 1782
  - St. Louis, Missouri, United States, 63141
    - Forest Investigative Site 1250
- Montana
  - Missoula, Montana, United States, 59808
    - Forest Investigative Site 1326
- Nebraska
  - Bellevue, Nebraska, United States, 68005
    - Forest Investigative Site 1028
  - Fremont, Nebraska, United States, 68025-2300
    - Forest Investigative Site 1388
  - Fremont, Nebraska, United States, 68025
    - Forest Investigative Site 1313
  - Omaha, Nebraska, United States, 68114
    - Forest Investigative Site 1035
  - Omaha, Nebraska, United States, 68134
    - Forest Investigative Site 1016
  - Omaha, Nebraska, United States, 68134
    - Forest Investigative Site 1254
  - Omaha, Nebraska, United States, 68144
    - Forest Investigative Site 1148
- Nevada
  - Henderson, Nevada, United States, 89014
    - Forest Investigative Site 1044
  - Henderson, Nevada, United States, 89052
    - Forest Investigative Site 1052
  - Las Vegas, Nevada, United States, 89101
    - Forest Investigative Site 1011
  - Las Vegas, Nevada, United States, 89103
    - Forest Investigative Site 1376
  - Las Vegas, Nevada, United States, 89104
    - Forest Investigative Site 1019
  - Las Vegas, Nevada, United States, 89123
    - Forest Investigative Site 1807
  - Las Vegas, Nevada, United States, 89148
    - Forest Investigative Site 1048
- New Jersey
  - Edison, New Jersey, United States, 08817
    - Forest Investigative Site 1709
  - Haddon Heights, New Jersey, United States, 08035
    - Forest Investigative Site 1132
  - Linden, New Jersey, United States, 07036
    - Forest Investigative Site 1141
  - Paramus, New Jersey, United States, 07652
    - Forest Investigative Site 1227
  - Trenton, New Jersey, United States, 08611
    - Forest Investigative Site 1169
  - Union, New Jersey, United States, 07083
    - Forest Investigative Site 1338
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Forest Investigative Site 1761
- New York
  - Brooklyn, New York, United States, 11203
    - Forest Investigative Site 1796
  - Buffalo, New York, United States, 14215
    - Forest Investigative Site 1151
  - Glen Falls, New York, United States, 12801
    - Forest Investigative Site 1021
  - Rochester, New York, United States, 14609
    - Forest Investigative Site 1115
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Forest Investigative Site 1040
  - Burlington, North Carolina, United States, 27215
    - Forest Investigative Site 1073
  - Cary, North Carolina, United States, 27519
    - Forest Investigative Site 1142
  - Charlotte, North Carolina, United States, 28209
    - Forest Investigative Site 1733
  - Charlotte, North Carolina, United States, 28277
    - Forest Investigative Site 1067
  - Dunn, North Carolina, United States, 28334
    - Forest Investigative Site 1342
  - Greensboro, North Carolina, United States, 27401
    - Forest Investigative Site 1088
  - Greensboro, North Carolina, United States, 27408
    - Forest Investigative Site 1385
  - Greensboro, North Carolina, United States, 27410
    - Forest Investigative Site 1309
  - Hickory, North Carolina, United States, 28601
    - Forest Investigative Site 1306
  - Hickory, North Carolina, United States, 28602
    - Forest Investigative Site 1098
  - Lenoir, North Carolina, United States, 28645
    - Forest Investigative Site 1110
  - Mooresville, North Carolina, United States, 28117
    - Forest Investigative Site 1272
  - Raleigh, North Carolina, United States, 27609
    - Forest Investigative Site 1024
  - Raleigh, North Carolina, United States, 27612
    - Forest Investigative Site 1789
  - Salisbury, North Carolina, United States, 28144
    - Forest Investigative Site 1715
  - Shelby, North Carolina, United States, 28152
    - Forest Investigative Site 1123
  - Wilmington, North Carolina, United States, 28401
    - Forest Investigative Site 1081
  - Wilmington, North Carolina, United States, 28401
    - Forest Investigative Site 1705
  - Winston-Salem, North Carolina, United States, 27103
    - Forest Investigative Site 1319
  - Winston-Salem, North Carolina, United States, 27103
    - Forest Investigative Site 1405
  - Winston-Salem, North Carolina, United States, 27103
    - Forest Investigative Site 1778
- Ohio
  - Akron, Ohio, United States, 44311
    - Forest Investigative Site 1203
  - Canal Fulton, Ohio, United States, 44614
    - Forest Investigative Site 1210
  - Cincinnati, Ohio, United States, 45219
    - Forest Investigative Site 1012
  - Cincinnati, Ohio, United States, 45219
    - Forest Investigative Site 1721
  - Cincinnati, Ohio, United States, 45224
    - Forest Investigative Site 1280
  - Cincinnati, Ohio, United States, 45227
    - Forest Investigative Site 1798
  - Cincinnati, Ohio, United States, 45236
    - Forest Investigative Site 1732
  - Cincinnati, Ohio, United States, 45242
    - Forest Investigative Site 1718
  - Cincinnati, Ohio, United States, 45246
    - Forest Investigative Site 1062
  - Cincinnati, Ohio, United States, 45249
    - Forest Investigative Site 1050
  - Cleveland, Ohio, United States, 44122
    - Forest Investigative Site 1084
  - Columbus, Ohio, United States, 43213
    - Forest Investigative Site 1765
  - Columbus, Ohio, United States, 43214
    - Forest Investigative Site 1395
  - Delaware, Ohio, United States, 43015
    - Forest Investigative Site 1209
  - Lyndhurst, Ohio, United States, 44124
    - Forest Investigative Site 1201
  - Maumee, Ohio, United States, 43537
    - Forest Investigative Site 1246
  - Mt. Gilead, Ohio, United States, 43338
    - Forest Investigative Site 1135
  - Perrysburg, Ohio, United States, 43551
    - Forest Investigative Site 1322
  - Willoughby, Ohio, United States, 44094
    - Forest Investigative Site 1231
  - Zanesville, Ohio, United States, 43701
    - Forest Investigative Site 1713
- Oklahoma
  - Norman, Oklahoma, United States, 73069
    - Forest Investigative Site 1195
  - Oklahoma City, Oklahoma, United States, 73103
    - Forest Investigative Site 1184
  - Oklahoma City, Oklahoma, United States, 73103
    - Forest Investigative Site 1305
  - Oklahoma City, Oklahoma, United States, 73103
    - Forest Investigative Site 1759
  - Yukon, Oklahoma, United States, 73099
    - Forest Investigative Site 1392
- Oregon
  - Ashland, Oregon, United States, 97520
    - Forest Investigative Site 1116
  - Eugene, Oregon, United States, 97402
    - Forest Investigative Site 1379
  - Eugene, Oregon, United States, 97404
    - Forest Investigative Site 1780
  - Hillsboro, Oregon, United States, 97123-4147
    - Forest Investigative Site 1108
  - Portland, Oregon, United States, 97225
    - Forest Investigative Site 1294
- Pennsylvania
  - Bensalem, Pennsylvania, United States, 19020
    - Forest Investigative Site 1109
  - Bensalem, Pennsylvania, United States, 19020
    - Forest Investigative Site 1291
  - Broomall, Pennsylvania, United States, 19008
    - Forest Investigative Site 1090
  - Carnegie, Pennsylvania, United States, 15106
    - Forest Investigative Site 1218
  - Downington, Pennsylvania, United States, 19335
    - Forest Investigative Site 1163
  - Erie, Pennsylvania, United States, 16508
    - Forest Investigative Site 1118
  - Erie, Pennsylvania, United States, 16509
    - Forest Investigative Site 1171
  - Holland, Pennsylvania, United States, 18966
    - Forest Investigative Site 1383
  - Jenkintown, Pennsylvania, United States, 19046
    - Forest Investigative Site 1720
  - Lansdale, Pennsylvania, United States, 19446
    - Forest Investigative Site 1207
  - Norristown, Pennsylvania, United States, 19401
    - Forest Investigative Site 1314
  - Penndel, Pennsylvania, United States, 19047
    - Forest Investigative Site 1198
  - Philadelphia, Pennsylvania, United States, 19152
    - Forest Investigative Site 1293
  - Pittsburgh, Pennsylvania, United States, 15216
    - Forest Investigative Site 1137
  - Red Lion, Pennsylvania, United States, 17356
    - Forest Investigative Site 1247
  - Tipton, Pennsylvania, United States, 16684
    - Forest Investigative Site 1791
  - Upper St. Clair, Pennsylvania, United States, 15241
    - Forest Investigative Site 1196
  - Warminster, Pennsylvania, United States, 18974
    - Forest Investigative Site 1172
  - West Chester, Pennsylvania, United States, 19382
    - Forest Investigative Site 1278
- Rhode Island
  - Warwick, Rhode Island, United States, 02886
    - Forest Investigative Site 1375
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - Forest Investigative Site 1760
  - Charleston, South Carolina, United States, 29412
    - Forest Investigative Site 1363
  - Columbia, South Carolina, United States, 29204
    - Forest Investigative Site 1122
  - Greenville, South Carolina, United States, 29615
    - Forest Investigative Site 1133
  - Greenville, South Carolina, United States, 29615
    - Forest Investigative Site 1809
  - Greer, South Carolina, United States, 29651
    - Forest Investigative Site 1327
  - Mt. Pleasant, South Carolina, United States, 29464
    - Forest Investigative Site 1127
  - Murrells Inlet, South Carolina, United States, 29576
    - Forest Investigative Site 1310
  - Pelzer, South Carolina, United States, 29669
    - Forest Investigative Site 1152
  - Simpsonville, South Carolina, United States, 29681
    - Forest Investigative Site 1114
  - Spartanburg, South Carolina, United States, 29303
    - Forest Investigative Site 1149
  - Summerville, South Carolina, United States, 29485
    - Forest Investigative Site 1113
  - Union, South Carolina, United States, 29379
    - Forest Investigative Site 1806
- South Dakota
  - Dakota Dunes, South Dakota, United States, 57049
    - Forest Investigative Site 1185
  - Rapid City, South Dakota, United States, 57702
    - Forest Investigative Site 1753
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Forest Investigative Site 1402
  - Chattanooga, Tennessee, United States, 37421
    - Forest Investigative Site 1037
  - Clarksville, Tennessee, United States, 37043
    - Forest Investigative Site 1031
  - Collierville, Tennessee, United States, 38107
    - Forest Investigative Site 1074
  - Fayetteville, Tennessee, United States, 37334
    - Forest Investigative Site 1033
  - Kingsport, Tennessee, United States, 37660
    - Forest Investigative Site 1763
  - Knoxville, Tennessee, United States, 37920
    - Forest Investigative Site 1744
  - Memphis, Tennessee, United States, 38119
    - Forest Investigative Site 1358
  - Memphis, Tennessee, United States, 38125
    - Forest Investigative Site 1082
- Texas
  - Arlington, Texas, United States, 76012
    - Forest Investigative Site 1094
  - Austin, Texas, United States, 78728
    - Forest Investigative Site 1245
  - Austin, Texas, United States, 78756
    - Forest Investigative Site 1311
  - Beaumont, Texas, United States, 77701
    - Forest Investigative Site 1174
  - Boerne, Texas, United States, 78006
    - Forest Investigative Site 1762
  - Bryan, Texas, United States, 77802
    - Forest Investigative Site 1244
  - Carrollton, Texas, United States, 75006
    - Forest Investigative Site 1776
  - Corpus Christi, Texas, United States, 78404
    - Forest Investigative Site 1205
  - Corsicana, Texas, United States, 75110
    - Forest Investigative Site 1268
  - Dallas, Texas, United States, 75235
    - Forest Investigative Site 1213
  - Houston, Texas, United States, 77024
    - Forest Investigative Site 1228
  - Houston, Texas, United States, 77024
    - Forest Investigative Site 1372
  - Houston, Texas, United States, 77030
    - Forest Investigative Site 1777
  - Houston, Texas, United States, 77036
    - Forest Investigative Site 1157
  - Houston, Texas, United States, 77062
    - Forest Investigative Site 1360
  - Houston, Texas, United States, 77074
    - Forest Investigative Site 1230
  - Houston, Texas, United States, 77081
    - Forest Investigative Site 1774
  - Irving, Texas, United States, 75039
    - Forest Investigative Site 1262
  - Longview, Texas, United States, 75605
    - Forest Investigative Site 1229
  - New Braunfels, Texas, United States, 78130
    - Forest Investigative Site 1199
  - Plano, Texas, United States, 75024
    - Forest Investigative Site 1214
  - San Antonio, Texas, United States, 78205
    - Forest Investigative Site 1129
  - San Antonio, Texas, United States, 78209
    - Forest Investigative Site 1766
  - San Antonio, Texas, United States, 78215
    - Forest Investigative Site 1797
  - San Antonio, Texas, United States, 78218
    - Forest Investigative Site 1295
  - San Antonio, Texas, United States, 78229
    - Forest Investigative Site 1167
  - San Antonio, Texas, United States, 78229
    - Forest Investigative Site 1186
  - San Antonio, Texas, United States, 78229
    - Forest Investigative Site 1257
  - San Antonio, Texas, United States, 78229
    - Forest Investigative Site 1317
  - San Antonio, Texas, United States, 78229
    - Forest Investigative Site 1758
  - Sugar Land, Texas, United States, 77478
    - Forest Investigative Site 1334
  - Tomball, Texas, United States, 77375
    - Forest Investigative Site 1269
  - Waco, Texas, United States, 76710
    - Forest Investigative Site 1349
- Utah
  - Clinton, Utah, United States, 84015
    - Forest Investigative Site 1015
  - Draper, Utah, United States, 84020
    - Forest Investigative Site 1187
  - Draper, Utah, United States, 84020
    - Forest Investigative Site 1226
  - Magna, Utah, United States, 84044
    - Forest Investigative Site 1086
  - Ogden, Utah, United States, 84405
    - Forest Investigative Site 1216
  - Orem, Utah, United States, 84058
    - Forest Investigative Site 1219
  - Riverton, Utah, United States, 84065
    - Forest Investigative Site 1328
  - Salt Lake City, Utah, United States, 84102
    - Forest Investigative Site 1771
  - Salt Lake City, Utah, United States, 84107
    - Forest Investigative Site 1175
  - Salt Lake City, Utah, United States, 84109
    - Forest Investigative Site 1197
  - Salt Lake City, Utah, United States, 84121
    - Forest Investigative Site 1194
  - South Jordan, Utah, United States, 84095
    - Forest Investigative Site 1202
  - St. George, Utah, United States, 84790
    - Forest Investigative Site 1773
- Virginia
  - Arlington, Virginia, United States, 22203
    - Forest Investigative Site 1786
  - Arlington, Virginia, United States, 22205
    - Forest Investigative Site 1130
  - Burke, Virginia, United States, 22015
    - Forest Investigative Site 1020
  - Danville, Virginia, United States, 24541
    - Forest Investigative Site 1343
  - Manassas, Virginia, United States, 20110
    - Forest Investigative Site 1164
  - Norfolk, Virginia, United States, 23510
    - Forest Investigative Site 1767
  - Petersburg, Virginia, United States, 23803
    - Forest Investigative Site 1292
  - Suffolk, Virginia, United States, 23435
    - Forest Investigative Site 1131
  - Virginia Beach, Virginia, United States, 23454
    - Forest Investigative Site 1099
- Washington
  - Port Orchard, Washington, United States, 98366
    - Forest Investigative Site 1119
  - Seattle, Washington, United States, 98104
    - Forest Investigative Site 1394
  - Spokane, Washington, United States, 99207
    - Forest Investigative Site 1085
  - Walla Walla, Washington, United States, 99362
    - Forest Investigative Site 1335
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - Forest Investigative Site 1377
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Forest Investigative Site 1367

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female outpatients of age 18 years or above
Patients diagnosed with stage 1 or stage 2 essential hypertension
Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

Secondary hypertension or severe hypertension
Clinically significant cardiovascular disease or heart failure
Clinical significant respiratory disease that would prohibit the use of a beta blocker
A medical contraindication to discontinuing a current antihypertensive therapy
History of Type 1 diabetes mellitus
History of Severe Mental Illness except mild depression

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: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nebivolol and Valsartan Fixed Dose Combination 1 Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg	Drug: Nebivolol and Valsartan 1 Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg, oral administration, then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration
Experimental: Nebivolol and Valsartan Fixed Dose Combination 2 Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg	Drug: Nebivolol and Valsartan 2 Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 320 mg, oral administration
Experimental: Nebivolol and Valsartan Fixed Dose Combination 3 Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg	Drug: Nebivolol and Valsartan 3 Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 20 mg and Valsartan 320 mg, oral administration
Experimental: Nebivolol Low Dose Nebivolol Monotherapy 5 mg	Drug: Nebivolol 1 Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
Experimental: Nebivolol High Dose Nebivolol Monotherapy 20 mg	Drug: Nebivolol 2 Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
Experimental: Valsartan Low Dose Valsartan Monotherapy 80 mg	Drug: Valsartan 1 Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
Experimental: Valsartan High Dose Valsartan Monotherapy 160 mg	Drug: Valsartan 2 Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
Placebo Comparator: Placebo Dose Matched placebo	Drug: Placebo Dose matched placebo, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Sitting Diastolic Blood Pressure (DBP) Time Frame: from basline to Week 8	from basline to Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Sitting Systolic Blood Pressure (SBP) Time Frame: from baseline to Week 8	from baseline to Week 8

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Investigators

Study Director: David B Bharucha, MD, PhD, FACC, Forest Laboratories

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

Giles TD, Weber MA, Basile J, Gradman AH, Bharucha DB, Chen W, Pattathil M; NAC-MD-01 Study Investigators. Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study. Lancet. 2014 May 31;383(9932):1889-98. doi: 10.1016/S0140-6736(14)60614-0. Erratum In: Lancet. 2016 Sep 24;388(10051):1280.

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

January 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NAC-MD-01

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

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 (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Stage 2 Hypertension

Clinical Trials on Nebivolol and Valsartan 1

Search Similar Trials

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Conditions

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