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
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
1 other identifier
interventional
4,161
1 country
413
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2012
Shorter than P25 for phase_3
413 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 9, 2012
CompletedFirst Posted
Study publicly available on registry
January 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedApril 25, 2014
March 1, 2014
1.2 years
January 9, 2012
March 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Sitting Diastolic Blood Pressure (DBP)
from basline to Week 8
Secondary Outcomes (1)
Change in Sitting Systolic Blood Pressure (SBP)
from baseline to Week 8
Study Arms (8)
Nebivolol and Valsartan Fixed Dose Combination 1
EXPERIMENTALFixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg
Nebivolol and Valsartan Fixed Dose Combination 2
EXPERIMENTALFixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg
Nebivolol and Valsartan Fixed Dose Combination 3
EXPERIMENTALFixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg
Nebivolol Low Dose
EXPERIMENTALNebivolol Monotherapy 5 mg
Nebivolol High Dose
EXPERIMENTALNebivolol Monotherapy 20 mg
Valsartan Low Dose
EXPERIMENTALValsartan Monotherapy 80 mg
Valsartan High Dose
EXPERIMENTALValsartan Monotherapy 160 mg
Placebo
PLACEBO COMPARATORDose Matched placebo
Interventions
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
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
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
Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (413)
Forest Investigative Site 1750
Birmingham, Alabama, 35216, United States
Forest Investigative Site 1038
Birmingham, Alabama, 35235, United States
Forest Investigative Site 1308
Birmingham, Alabama, 35235, United States
Forest Investigative Site 1192
Birmingham, Alabama, 35242, United States
Forest Investigative Site 1005
Birmingham, Alabama, 35294, United States
Forest Investigative Site 1047
Foley, Alabama, 36535, United States
Forest Investigative Site 1717
Gulf Shores, Alabama, 36542, United States
Forest Investigative Site 1056
Mobile, Alabama, 36617, United States
Forest Investigative Site 1719
Muscle Shoals, Alabama, 35662, United States
Forest Investigative Site 1145
Glendale, Arizona, 85308, United States
Forest Investigative Site 1703
Goodyear, Arizona, 85395, United States
Forest Investigative Site 1757
Mesa, Arizona, 85202, United States
Forest Investigative Site 1170
Phoenix, Arizona, 85015, United States
Forest Investigative Site 1238
Phoenix, Arizona, 85018, United States
Forest Investigative Site 1204
Phoenix, Arizona, 85020, United States
Forest Investigative Site 1755
Phoenix, Arizona, 85020, United States
Forest Investigative Site 1259
Phoenix, Arizona, 85032, United States
Forest Investigative Site 1001
Phoenix, Arizona, 85050, United States
Forest Investigative Site 1078
Scottsdale, Arizona, 85251, United States
Forest Investigative Site 1225
Tempe, Arizona, 85282, United States
Forest Investigative Site 1712
Tempe, Arizona, 85282, United States
Forest Investigative Site 1089
Tempe, Arizona, 85283, United States
Forest Investigative Site 1065
Tucson, Arizona, 85704, United States
Forest Investigative Site 1340
Tucson, Arizona, 85712, United States
Forest Investigative Site 1331
Tucson, Arizona, 85745, United States
Forest Investigative Site 1290
Little Rock, Arkansas, 72204, United States
Forest Investigative Site 1138
Little Rock, Arkansas, 72211, United States
Forest Investigative Site 1371
Pine Bluff, Arkansas, 71603, United States
Forest Investigative Site 1220
Searcy, Arkansas, 72143, United States
Forest Investigative Site 1063
Buena Park, California, 90620, United States
Forest Investigative Site 1743
Burbank, California, 91505, United States
Forest Investigative Site 1006
Carmichael, California, 95608, United States
Forest Investigative Site 1384
Chino, California, 91710, United States
Forest Investigative Site 1190
Chula Vista, California, 91911, United States
Forest Investigative Site 1178
Costa Mesa, California, 92626, United States
Forest Investigative Site 1043
Diamond Bar, California, 91765, United States
Forest Investigative Site 1362
Encinitas, California, 92024, United States
Forest Investigative Site 1144
Fresno, California, 93721, United States
Forest Investigative Site 1095
Fresno, California, 93726, United States
Forest Investigative Site 1710
Garden Grove, California, 92844, United States
Forest Investigative Site 1022
Greenbrae, California, 94904, United States
Forest Investigative Site 1370
Huntington Beach, California, 92647, United States
Forest Investigative Site 1704
Huntington Park, California, 90255, United States
Forest Investigative Site 1725
Huntington Park, California, 90255, United States
Forest Investigative Site 1742
La Mesa, California, 91942, United States
Forest Investigative Site 1381
Lomita, California, 90717, United States
Forest Investigative Site 1706
Long Beach, California, 90806, United States
Forest Investigative Site 1248
Los Angelas, California, 90057, United States
Forest Investigative Site 1785
Los Angelas, California, 90057, United States
Forest Investigative Site 1029
Los Angeles, California, 90017, United States
Forest Investigative Site 1361
Los Angeles, California, 90017, United States
Forest Investigative Site 1102
Los Angeles, California, 90036, United States
Forest Investigative Site 1054
Mission Hills, California, 91345, United States
Forest Investigative Site 1386
Moreno Valley, California, 92553, United States
Forest Investigative Site 1756
Newport Beach, California, 92663, United States
Forest Investigative Site 1181
Northridge, California, 91325, United States
Forest Investigative Site 1212
Orange, California, 92868, United States
Forest Investigative Site 1101
Palm Springs, California, 92262, United States
Forest Investigative Site 1014
Paramount, California, 90723, United States
Forest Investigative Site 1150
Pismo Beach, California, 93449, United States
Forest Investigative Site 1009
Riverside, California, 92506, United States
Forest Investigative Site 1241
Roseville, California, 95661, United States
Forest Investigative Site 1046
Sacramento, California, 95816, United States
Forest Investigative Site 1193
Sacramento, California, 95821, United States
Forest Investigative Site 1296
Sacramento, California, 95823, United States
Forest Investigative Site 1716
Sacramento, California, 95825, United States
Forest Investigative Site 1096
San Bernardino, California, 92404, United States
Forest Investigative Site 1189
San Diego, California, 92056, United States
Forest Investigative Site 1279
San Diego, California, 92103, United States
Forest Investigative Site 1354
San Diego, California, 92114, United States
Forest Investigative Site 1724
San Diego, California, 92117, United States
Forest Investigative Site 1106
San Diego, California, 92120, United States
Forest Investigative Site 1027
San Francisco, California, 94115, United States
Forest Investigative Site 1017
San Marino, California, 91108, United States
Forest Investigative Site 1158
San Ramon, California, 94583, United States
Forest Investigative Site 1318
Santa Ana, California, 92705, United States
Forest Investigative Site 1239
Spring Valley, California, 91978, United States
Forest Investigative Site 1792
Stockton, California, 95204, United States
Forest Investigative Site 1301
Sylmar, California, 91342, United States
Forest Investigative Site 1066
Temecula, California, 92591, United States
Forest Investigative Site 1729
Tustin, California, 92781, United States
Forest Investigative Site 1783
Westlake Village, California, 91361, United States
Forest Investigative Site 1162
Colorado Springs, Colorado, 80904, United States
Forest Investigative Site 1270
Denver, Colorado, 80209, United States
Forest Investigative Site 1711
Denver, Colorado, 80220, United States
Forest Investigative Site 1013
Northglenn, Colorado, 80234, United States
Forest Investigative Site 1400
Thornton, Colorado, 80233, United States
Forest Investigative Site 1324
Bridgeport, Connecticut, 06610, United States
Forest Investigative Site 1045
Cromwell, Connecticut, 06416, United States
Forest Investigative Site 1059
Stamford, Connecticut, 06905, United States
Forest Investigative Site 1072
Waterbury, Connecticut, 06708, United States
Forest Investigative Site 1159
Boca Raton, Florida, 33432, United States
Forest Investigative Site 1007
Bradenton, Florida, 34208, United States
Forest Investigative Site 1042
Brandon, Florida, 33511, United States
Forest Investigative Site 1702
Brooksville, Florida, 34601, United States
Forest Investigative Site 1764
Clearwater, Florida, 33756, United States
Forest Investigative Site 1182
Coral Gables, Florida, 33134, United States
Forest Investigative Site 1249
Coral Gables, Florida, 33134, United States
Forest Investigative Site 1221
Cutler Bay, Florida, 33189, United States
Forest Investigative Site 1793
Daytona Beach, Florida, 32117, United States
Forest Investigative Site 1266
Deerfield Beach, Florida, 33441, United States
Forest Investigative Site 1100
DeFuniak Springs, Florida, 32435, United States
Forest Investigative Site 1734
DeLand, Florida, 32720, United States
Forest Investigative Site 1775
Doral, Florida, 33166, United States
Forest Investigative Site 1378
Doral, Florida, 33172, United States
Forest Investigative Site 1237
Edgewater, Florida, 32132, United States
Forest Investigative Site 1068
Fort Lauderdale, Florida, 33306, United States
Forest Investigative Site 1026
Fort Lauderdale, Florida, 33308, United States
Forest Investigative Site 1330
Fort Lauderdale, Florida, 33319, United States
Forest Investigative Site 1794
Gainsville, Florida, 32605, United States
Forest Investigative Site 1261
Hallandale, Florida, 33009, United States
Forest Investigative Site 1240
Hialeah, Florida, 33012, United States
Forest Investigative Site 1260
Hialeah, Florida, 33012, United States
Forest Investigative Site 1155
Hollywood, Florida, 33021, United States
Forest Investigative Site 1233
Jacksonville, Florida, 32216, United States
Forest Investigative Site 1253
Jacksonville, Florida, 32216, United States
Forest Investigative Site 1264
Jacksonville, Florida, 32216, United States
Forest Investigative Site 1256
Jacksonville, Florida, 32223, United States
Forest Investigative Site 1077
Jupiter, Florida, 33458, United States
Forest Investigative Site 1041
Kissimmee, Florida, 34741, United States
Forest Investigative Site 1399
Kissimmee, Florida, 34741, United States
Forest Investigative Site 1784
Miami, Florida, 33014, United States
Forest Investigative Site 1364
Miami, Florida, 33125, United States
Forest Investigative Site 1206
Miami, Florida, 33135, United States
Forest Investigative Site 1397
Miami, Florida, 33136, United States
Forest Investigative Site 1180
Miami, Florida, 33143, United States
Forest Investigative Site 1396
Miami, Florida, 33144, United States
Forest Investigative Site 1154
Miami, Florida, 33155, United States
Forest Investigative Site 1788
Miami, Florida, 33169, United States
Forest Investigative Site 1223
Miami, Florida, 33183, United States
Forest Investigative Site 1707
Miami, Florida, 33185, United States
Forest Investigative Site 1282
Miami, Florida, 33186, United States
Forest Investigative Site 1297
Miami Springs, Florida, 33166, United States
Forest Investigative Site 1708
New Port Richey, Florida, 34652, United States
Forest Investigative Site 1176
North Miami Beach, Florida, 33162, United States
Forest Investigative Site 1284
Oldsmar, Florida, 34677, United States
Forest Investigative Site 1232
Opa-locka, Florida, 33054, United States
Forest Investigative Site 1802
Orlando, Florida, 32806, United States
Forest Investigative Site 1049
Orlando, Florida, 32811, United States
Forest Investigative Site 1235
Orlando, Florida, 32822, United States
Forest Investigative Site 1741
Ormond Beach, Florida, 32174, United States
Forest Investigative Site 1003
Oviedo, Florida, 32765, United States
Forest Investigative Site 1369
Palm Harbor, Florida, 34684, United States
Forest Investigative Site 1079
Pembroke Pines, Florida, 33024, United States
Forest Investigative Site 1053
Pembroke Pines, Florida, 33026, United States
Forest Investigative Site 1055
Pembroke Pines, Florida, 33028, United States
Forest Investigative Site 1161
Pembroke Pines, Florida, 33028, United States
Forest Investigative Site 1166
Pembroke Pines, Florida, 33028, United States
Forest Investigative Site 1224
Pembroke Pines, Florida, 33028, United States
Forest Investigative Site 1075
Pembroke Pines, Florida, 33029, United States
Forest Investigative Site 1368
Pinellas Park, Florida, 33782, United States
Forest Investigative Site 1023
Plant City, Florida, 33563, United States
Forest Investigative Site 1737
Ponte Vedra, Florida, 32081, United States
Forest Investigative Site 1749
Port Orange, Florida, 32127, United States
Forest Investigative Site 1069
Saint Cloud, Florida, 34769, United States
Forest Investigative Site 1315
Saint Cloud, Florida, 34769, United States
Forest Investigative Site 1739
South Miami, Florida, 33143, United States
Forest Investigative Site 1243
St. Petersburg, Florida, 33701, United States
Forest Investigative Site 1723
St. Petersburg, Florida, 33709, United States
Forest Investigative Site 1730
St. Petersburg, Florida, 33716, United States
Forest Investigative Site 1076
Tamarack, Florida, 33321, United States
Forest Investigative Site 1032
Tampa, Florida, 33606, United States
Forest Investigative Site 1302
Tampa, Florida, 33607, United States
Forest Investigative Site 1120
Winter Haven, Florida, 33880, United States
Forest Investigative Site 1281
Atlanta, Georgia, 30308, United States
Forest Investigative Site 1745
Atlanta, Georgia, 30338, United States
Forest Investigative Site 1080
Blue Ridge, Georgia, 30513, United States
Forest Investigative Site 1236
Lilburn, Georgia, 30047, United States
Forest Investigative Site 1389
Marietta, Georgia, 30060, United States
Forest Investigative Site 1002
Marietta, Georgia, 30066, United States
Forest Investigative Site 1390
Oakwood, Georgia, 30566, United States
Forest Investigative Site 1333
Sandy Springs, Georgia, 30328, United States
Forest Investigative Site 1332
Savannah, Georgia, 31419, United States
Forest Investigative Site 1252
Snellville, Georgia, 30039, United States
Forest Investigative Site 1353
Snellville, Georgia, 30078, United States
Forest Investigative Site 1740
Stockbridge, Georgia, 30281, United States
Forest Investigative Site 1173
Woodstock, Georgia, 30189, United States
Forest Investigative Site 1018
Honolulu, Hawaii, 96814, United States
Forest Investigative Site 1398
Blackfoot, Idaho, 83221, United States
Forest Investigative Site 1727
Boise, Idaho, 83704, United States
Forest Investigative Site 1387
Hayden Lake, Idaho, 83835, United States
Forest Investigative Site 1004
Meridian, Idaho, 83646, United States
Forest Investigative Site 1039
Nampa, Idaho, 83686, United States
Forest Investigative Site 1790
Addison, Illinois, 60101, United States
Forest Investigative Site 1093
Arlington Heights, Illinois, 60004, United States
Forest Investigative Site 1747
Chicago, Illinois, 60607, United States
Forest Investigative Site 1071
Chicago, Illinois, 60611, United States
Forest Investigative Site 1752
Chicago, Illinois, 60616, United States
Forest Investigative Site 1403
Hazel Crest, Illinois, 60429, United States
Forest Investigative Site 1126
Morton, Illinois, 61550, United States
Forest Investigative Site 1283
O'Fallon, Illinois, 62269, United States
Forest Investigative Site 1091
Evansville, Indiana, 47710, United States
Forest Investigative Site 1103
Evansville, Indiana, 47712, United States
Forest Investigative Site 1147
Muncie, Indiana, 47304, United States
Forest Investigative Site 1107
Augusta, Kansas, 67010, United States
Forest Investigative Site 1345
Hutchinson, Kansas, 67502, United States
Forest Investigative Site 1805
Lenexa, Kansas, 66219, United States
Forest Investigative Site 1255
Mission, Kansas, 66202, United States
Forest Investigative Site 1092
Newton, Kansas, 67114, United States
Forest Investigative Site 1801
Crestview Hills, Kentucky, 41017, United States
Forest Investigative Site 1366
Lexington, Kentucky, 40509, United States
Forest Investigative Site 1770
Louisville, Kentucky, 40213, United States
Forest Investigative Site 1177
Madisonville, Kentucky, 42431, United States
Forest Investigative Site 1251
Baton Rouge, Louisiana, 70808, United States
Forest Investigative Site 1215
Covington, Louisiana, 70433, United States
Forest Investigative Site 1274
Eunice, Louisiana, 70535, United States
Forest Investigative Site 1323
Metairie, Louisiana, 70006, United States
Forest Investigative Site 1795
Metairie, Louisiana, 77002, United States
Forest Investigative Site 1285
New Orleans, Louisiana, 70115, United States
Forest Investigative Site 1779
New Orleans, Louisiana, 70119, United States
Forest Investigative Site 1769
Auburn, Maine, 04210, United States
Forest Investigative Site 1125
Baltimore, Maryland, 21209, United States
Forest Investigative Site 1263
Baltimore, Maryland, 21236, United States
Forest Investigative Site 1128
Lutherville, Maryland, 21093, United States
Forest Investigative Site 1726
Haverhill, Massachusetts, 01830, United States
Forest Investigative Site 1061
Hyannis, Massachusetts, 02601, United States
Forest Investigative Site 1728
North Dartmouth, Massachusetts, 02747, United States
Forest Investigative Site 1356
Watertown, Massachusetts, 02472-3930, United States
Forest Investigative Site 1336
Chelsea, Michigan, 48118, United States
Forest Investigative Site 1097
Flint, Michigan, 48504, United States
Forest Investigative Site 1165
Kalamazoo, Michigan, 49009, United States
Forest Investigative Site 1337
Stevensville, Michigan, 49127, United States
Forest Investigative Site 1768
Traverse City, Michigan, 49684, United States
Forest Investigative Site 1064
Troy, Michigan, 48085, United States
Forest Investigative Site 1025
Belzoni, Mississippi, 39038, United States
Forest Investigative Site 1057
Jackson, Mississippi, 39289-1214, United States
Forest Investigative Site 1034
Olive Branch, Mississippi, 38654, United States
Forest Investigative Site 1271
Picayune, Mississippi, 39466, United States
Forest Investigative Site 1782
Kansas City, Missouri, 64111, United States
Forest Investigative Site 1250
St Louis, Missouri, 63141, United States
Forest Investigative Site 1326
Missoula, Montana, 59808, United States
Forest Investigative Site 1028
Bellevue, Nebraska, 68005, United States
Forest Investigative Site 1388
Fremont, Nebraska, 68025-2300, United States
Forest Investigative Site 1313
Fremont, Nebraska, 68025, United States
Forest Investigative Site 1035
Omaha, Nebraska, 68114, United States
Forest Investigative Site 1016
Omaha, Nebraska, 68134, United States
Forest Investigative Site 1254
Omaha, Nebraska, 68134, United States
Forest Investigative Site 1148
Omaha, Nebraska, 68144, United States
Forest Investigative Site 1044
Henderson, Nevada, 89014, United States
Forest Investigative Site 1052
Henderson, Nevada, 89052, United States
Forest Investigative Site 1011
Las Vegas, Nevada, 89101, United States
Forest Investigative Site 1376
Las Vegas, Nevada, 89103, United States
Forest Investigative Site 1019
Las Vegas, Nevada, 89104, United States
Forest Investigative Site 1807
Las Vegas, Nevada, 89123, United States
Forest Investigative Site 1048
Las Vegas, Nevada, 89148, United States
Forest Investigative Site 1709
Edison, New Jersey, 08817, United States
Forest Investigative Site 1132
Haddon Heights, New Jersey, 08035, United States
Forest Investigative Site 1141
Linden, New Jersey, 07036, United States
Forest Investigative Site 1227
Paramus, New Jersey, 07652, United States
Forest Investigative Site 1169
Trenton, New Jersey, 08611, United States
Forest Investigative Site 1338
Union, New Jersey, 07083, United States
Forest Investigative Site 1761
Albuquerque, New Mexico, 87102, United States
Forest Investigative Site 1796
Brooklyn, New York, 11203, United States
Forest Investigative Site 1151
Buffalo, New York, 14215, United States
Forest Investigative Site 1021
Glen Falls, New York, 12801, United States
Forest Investigative Site 1115
Rochester, New York, 14609, United States
Forest Investigative Site 1040
Asheboro, North Carolina, 27203, United States
Forest Investigative Site 1073
Burlington, North Carolina, 27215, United States
Forest Investigative Site 1142
Cary, North Carolina, 27519, United States
Forest Investigative Site 1733
Charlotte, North Carolina, 28209, United States
Forest Investigative Site 1067
Charlotte, North Carolina, 28277, United States
Forest Investigative Site 1342
Dunn, North Carolina, 28334, United States
Forest Investigative Site 1088
Greensboro, North Carolina, 27401, United States
Forest Investigative Site 1385
Greensboro, North Carolina, 27408, United States
Forest Investigative Site 1309
Greensboro, North Carolina, 27410, United States
Forest Investigative Site 1306
Hickory, North Carolina, 28601, United States
Forest Investigative Site 1098
Hickory, North Carolina, 28602, United States
Forest Investigative Site 1110
Lenoir, North Carolina, 28645, United States
Forest Investigative Site 1272
Mooresville, North Carolina, 28117, United States
Forest Investigative Site 1024
Raleigh, North Carolina, 27609, United States
Forest Investigative Site 1789
Raleigh, North Carolina, 27612, United States
Forest Investigative Site 1715
Salisbury, North Carolina, 28144, United States
Forest Investigative Site 1123
Shelby, North Carolina, 28152, United States
Forest Investigative Site 1081
Wilmington, North Carolina, 28401, United States
Forest Investigative Site 1705
Wilmington, North Carolina, 28401, United States
Forest Investigative Site 1319
Winston-Salem, North Carolina, 27103, United States
Forest Investigative Site 1405
Winston-Salem, North Carolina, 27103, United States
Forest Investigative Site 1778
Winston-Salem, North Carolina, 27103, United States
Forest Investigative Site 1203
Akron, Ohio, 44311, United States
Forest Investigative Site 1210
Canal Fulton, Ohio, 44614, United States
Forest Investigative Site 1012
Cincinnati, Ohio, 45219, United States
Forest Investigative Site 1721
Cincinnati, Ohio, 45219, United States
Forest Investigative Site 1280
Cincinnati, Ohio, 45224, United States
Forest Investigative Site 1798
Cincinnati, Ohio, 45227, United States
Forest Investigative Site 1732
Cincinnati, Ohio, 45236, United States
Forest Investigative Site 1718
Cincinnati, Ohio, 45242, United States
Forest Investigative Site 1062
Cincinnati, Ohio, 45246, United States
Forest Investigative Site 1050
Cincinnati, Ohio, 45249, United States
Forest Investigative Site 1084
Cleveland, Ohio, 44122, United States
Forest Investigative Site 1765
Columbus, Ohio, 43213, United States
Forest Investigative Site 1395
Columbus, Ohio, 43214, United States
Forest Investigative Site 1209
Delaware, Ohio, 43015, United States
Forest Investigative Site 1201
Lyndhurst, Ohio, 44124, United States
Forest Investigative Site 1246
Maumee, Ohio, 43537, United States
Forest Investigative Site 1135
Mount Gilead, Ohio, 43338, United States
Forest Investigative Site 1322
Perrysburg, Ohio, 43551, United States
Forest Investigative Site 1231
Willoughby, Ohio, 44094, United States
Forest Investigative Site 1713
Zanesville, Ohio, 43701, United States
Forest Investigative Site 1195
Norman, Oklahoma, 73069, United States
Forest Investigative Site 1184
Oklahoma City, Oklahoma, 73103, United States
Forest Investigative Site 1305
Oklahoma City, Oklahoma, 73103, United States
Forest Investigative Site 1759
Oklahoma City, Oklahoma, 73103, United States
Forest Investigative Site 1392
Yukon, Oklahoma, 73099, United States
Forest Investigative Site 1116
Ashland, Oregon, 97520, United States
Forest Investigative Site 1379
Eugene, Oregon, 97402, United States
Forest Investigative Site 1780
Eugene, Oregon, 97404, United States
Forest Investigative Site 1108
Hillsboro, Oregon, 97123-4147, United States
Forest Investigative Site 1294
Portland, Oregon, 97225, United States
Forest Investigative Site 1109
Bensalem, Pennsylvania, 19020, United States
Forest Investigative Site 1291
Bensalem, Pennsylvania, 19020, United States
Forest Investigative Site 1090
Broomall, Pennsylvania, 19008, United States
Forest Investigative Site 1218
Carnegie, Pennsylvania, 15106, United States
Forest Investigative Site 1163
Downington, Pennsylvania, 19335, United States
Forest Investigative Site 1118
Erie, Pennsylvania, 16508, United States
Forest Investigative Site 1171
Erie, Pennsylvania, 16509, United States
Forest Investigative Site 1383
Holland, Pennsylvania, 18966, United States
Forest Investigative Site 1720
Jenkintown, Pennsylvania, 19046, United States
Forest Investigative Site 1207
Lansdale, Pennsylvania, 19446, United States
Forest Investigative Site 1314
Norristown, Pennsylvania, 19401, United States
Forest Investigative Site 1198
Penndel, Pennsylvania, 19047, United States
Forest Investigative Site 1293
Philadelphia, Pennsylvania, 19152, United States
Forest Investigative Site 1137
Pittsburgh, Pennsylvania, 15216, United States
Forest Investigative Site 1247
Red Lion, Pennsylvania, 17356, United States
Forest Investigative Site 1791
Tipton, Pennsylvania, 16684, United States
Forest Investigative Site 1196
Upper Saint Clair, Pennsylvania, 15241, United States
Forest Investigative Site 1172
Warminster, Pennsylvania, 18974, United States
Forest Investigative Site 1278
West Chester, Pennsylvania, 19382, United States
Forest Investigative Site 1375
Warwick, Rhode Island, 02886, United States
Forest Investigative Site 1760
Charleston, South Carolina, 29407, United States
Forest Investigative Site 1363
Charleston, South Carolina, 29412, United States
Forest Investigative Site 1122
Columbia, South Carolina, 29204, United States
Forest Investigative Site 1133
Greenville, South Carolina, 29615, United States
Forest Investigative Site 1809
Greenville, South Carolina, 29615, United States
Forest Investigative Site 1327
Greer, South Carolina, 29651, United States
Forest Investigative Site 1127
Mt. Pleasant, South Carolina, 29464, United States
Forest Investigative Site 1310
Murrells Inlet, South Carolina, 29576, United States
Forest Investigative Site 1152
Pelzer, South Carolina, 29669, United States
Forest Investigative Site 1114
Simpsonville, South Carolina, 29681, United States
Forest Investigative Site 1149
Spartanburg, South Carolina, 29303, United States
Forest Investigative Site 1113
Summerville, South Carolina, 29485, United States
Forest Investigative Site 1806
Union, South Carolina, 29379, United States
Forest Investigative Site 1185
Dakota Dunes, South Dakota, 57049, United States
Forest Investigative Site 1753
Rapid City, South Dakota, 57702, United States
Forest Investigative Site 1402
Bristol, Tennessee, 37620, United States
Forest Investigative Site 1037
Chattanooga, Tennessee, 37421, United States
Forest Investigative Site 1031
Clarksville, Tennessee, 37043, United States
Forest Investigative Site 1074
Collierville, Tennessee, 38107, United States
Forest Investigative Site 1033
Fayetteville, Tennessee, 37334, United States
Forest Investigative Site 1763
Kingsport, Tennessee, 37660, United States
Forest Investigative Site 1744
Knoxville, Tennessee, 37920, United States
Forest Investigative Site 1358
Memphis, Tennessee, 38119, United States
Forest Investigative Site 1082
Memphis, Tennessee, 38125, United States
Forest Investigative Site 1094
Arlington, Texas, 76012, United States
Forest Investigative Site 1245
Austin, Texas, 78728, United States
Forest Investigative Site 1311
Austin, Texas, 78756, United States
Forest Investigative Site 1174
Beaumont, Texas, 77701, United States
Forest Investigative Site 1762
Boerne, Texas, 78006, United States
Forest Investigative Site 1244
Bryan, Texas, 77802, United States
Forest Investigative Site 1776
Carrollton, Texas, 75006, United States
Forest Investigative Site 1205
Corpus Christi, Texas, 78404, United States
Forest Investigative Site 1268
Corsicana, Texas, 75110, United States
Forest Investigative Site 1213
Dallas, Texas, 75235, United States
Forest Investigative Site 1228
Houston, Texas, 77024, United States
Forest Investigative Site 1372
Houston, Texas, 77024, United States
Forest Investigative Site 1777
Houston, Texas, 77030, United States
Forest Investigative Site 1157
Houston, Texas, 77036, United States
Forest Investigative Site 1360
Houston, Texas, 77062, United States
Forest Investigative Site 1230
Houston, Texas, 77074, United States
Forest Investigative Site 1774
Houston, Texas, 77081, United States
Forest Investigative Site 1262
Irving, Texas, 75039, United States
Forest Investigative Site 1229
Longview, Texas, 75605, United States
Forest Investigative Site 1199
New Braunfels, Texas, 78130, United States
Forest Investigative Site 1214
Plano, Texas, 75024, United States
Forest Investigative Site 1129
San Antonio, Texas, 78205, United States
Forest Investigative Site 1766
San Antonio, Texas, 78209, United States
Forest Investigative Site 1797
San Antonio, Texas, 78215, United States
Forest Investigative Site 1295
San Antonio, Texas, 78218, United States
Forest Investigative Site 1167
San Antonio, Texas, 78229, United States
Forest Investigative Site 1186
San Antonio, Texas, 78229, United States
Forest Investigative Site 1257
San Antonio, Texas, 78229, United States
Forest Investigative Site 1317
San Antonio, Texas, 78229, United States
Forest Investigative Site 1758
San Antonio, Texas, 78229, United States
Forest Investigative Site 1334
Sugar Land, Texas, 77478, United States
Forest Investigative Site 1269
Tomball, Texas, 77375, United States
Forest Investigative Site 1349
Waco, Texas, 76710, United States
Forest Investigative Site 1015
Clinton, Utah, 84015, United States
Forest Investigative Site 1187
Draper, Utah, 84020, United States
Forest Investigative Site 1226
Draper, Utah, 84020, United States
Forest Investigative Site 1086
Magna, Utah, 84044, United States
Forest Investigative Site 1216
Ogden, Utah, 84405, United States
Forest Investigative Site 1219
Orem, Utah, 84058, United States
Forest Investigative Site 1328
Riverton, Utah, 84065, United States
Forest Investigative Site 1771
Salt Lake City, Utah, 84102, United States
Forest Investigative Site 1175
Salt Lake City, Utah, 84107, United States
Forest Investigative Site 1197
Salt Lake City, Utah, 84109, United States
Forest Investigative Site 1194
Salt Lake City, Utah, 84121, United States
Forest Investigative Site 1202
South Jordan, Utah, 84095, United States
Forest Investigative Site 1773
St. George, Utah, 84790, United States
Forest Investigative Site 1786
Arlington, Virginia, 22203, United States
Forest Investigative Site 1130
Arlington, Virginia, 22205, United States
Forest Investigative Site 1020
Burke, Virginia, 22015, United States
Forest Investigative Site 1343
Danville, Virginia, 24541, United States
Forest Investigative Site 1164
Manassas, Virginia, 20110, United States
Forest Investigative Site 1767
Norfolk, Virginia, 23510, United States
Forest Investigative Site 1292
Petersburg, Virginia, 23803, United States
Forest Investigative Site 1131
Suffolk, Virginia, 23435, United States
Forest Investigative Site 1099
Virginia Beach, Virginia, 23454, United States
Forest Investigative Site 1119
Port Orchard, Washington, 98366, United States
Forest Investigative Site 1394
Seattle, Washington, 98104, United States
Forest Investigative Site 1085
Spokane, Washington, 99207, United States
Forest Investigative Site 1335
Walla Walla, Washington, 99362, United States
Forest Investigative Site 1377
Charleston, West Virginia, 25304, United States
Forest Investigative Site 1367
Milwaukee, Wisconsin, 53215, United States
Related Publications (1)
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.
PMID: 24881993DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David B Bharucha, MD, PhD, FACC
Forest Laboratories
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2012
First Posted
January 11, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
April 25, 2014
Record last verified: 2014-03