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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01508026
First received: January 9, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Stage 1 Hypertension
Stage 2 Hypertension
Drug: Nebivolol and Valsartan 1
Drug: Nebivolol and Valsartan 2
Drug: Nebivolol and Valsartan 3
Drug: Nebivolol 1
Drug: Nebivolol 2
Drug: Valsartan 1
Drug: Valsartan 2
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change in Sitting Diastolic Blood Pressure (DBP) [ Time Frame: from basline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Sitting Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]

Enrollment: 4161
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508026

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

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01508026     History of Changes
Other Study ID Numbers: NAC-MD-01
Study First Received: January 9, 2012
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Forest Laboratories:
Stage 1
Stage 2
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Nebivolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014