AzTrials
AzTrials

Stage 1 HypertensionPhase 3NCT01508026

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 Phase 3 study testing Nebivolol and Valsartan 1, Nebivolol and Valsartan 2 and Nebivolol and Valsartan 3 in people with Stage 1 Hypertension and Stage 2 Hypertension, run by Forest Laboratories at 413 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage 1 Hypertension, Stage 2 Hypertension
What is being tested?
Nebivolol and Valsartan 1, Nebivolol and Valsartan 2 and Nebivolol and Valsartan 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,161 participants
Where
413 sitesUnited States
Study dates
Jan 2012to May 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

413 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Forest Investigative Site 1790

    Addison, Illinois, 60101

  • Forest Investigative Site 1203

    Akron, Ohio, 44311

  • Forest Investigative Site 1761

    Albuquerque, New Mexico, 87102

  • Forest Investigative Site 1094

    Arlington, Texas, 76012

  • Forest Investigative Site 1786

    Arlington, Virginia, 22203

  • Forest Investigative Site 1130

    Arlington, Virginia, 22205

  • Forest Investigative Site 1093

    Arlington Heights, Illinois, 60004

  • Forest Investigative Site 1040

    Asheboro, North Carolina, 27203

  • Forest Investigative Site 1116

    Ashland, Oregon, 97520

  • Forest Investigative Site 1281

    Atlanta, Georgia, 30308

  • Forest Investigative Site 1745

    Atlanta, Georgia, 30338

  • Forest Investigative Site 1769

    Auburn, Maine, 04210

  • Forest Investigative Site 1107

    Augusta, Kansas, 67010

  • Forest Investigative Site 1245

    Austin, Texas, 78728

  • Forest Investigative Site 1311

    Austin, Texas, 78756

  • Forest Investigative Site 1125

    Baltimore, Maryland, 21209

  • Forest Investigative Site 1263

    Baltimore, Maryland, 21236

  • Forest Investigative Site 1251

    Baton Rouge, Louisiana, 70808

  • Forest Investigative Site 1174

    Beaumont, Texas, 77701

  • Forest Investigative Site 1028

    Bellevue, Nebraska, 68005

  • Forest Investigative Site 1025

    Belzoni, Mississippi, 39038

  • Forest Investigative Site 1109

    Bensalem, Pennsylvania, 19020

  • Forest Investigative Site 1291

    Bensalem, Pennsylvania, 19020

  • Forest Investigative Site 1750

    Birmingham, Alabama, 35216

  • Forest Investigative Site 1038

    Birmingham, Alabama, 35235

  • Forest Investigative Site 1308

    Birmingham, Alabama, 35235

  • Forest Investigative Site 1192

    Birmingham, Alabama, 35242

  • Forest Investigative Site 1005

    Birmingham, Alabama, 35294

  • Forest Investigative Site 1398

    Blackfoot, Idaho, 83221

  • Forest Investigative Site 1080

    Blue Ridge, Georgia, 30513

  • Forest Investigative Site 1159

    Boca Raton, Florida, 33432

  • Forest Investigative Site 1762

    Boerne, Texas, 78006

  • Forest Investigative Site 1727

    Boise, Idaho, 83704

  • Forest Investigative Site 1007

    Bradenton, Florida, 34208

  • Forest Investigative Site 1042

    Brandon, Florida, 33511

  • Forest Investigative Site 1324

    Bridgeport, Connecticut, 06610

  • Forest Investigative Site 1402

    Bristol, Tennessee, 37620

  • Forest Investigative Site 1796

    Brooklyn, New York, 11203

  • Forest Investigative Site 1702

    Brooksville, Florida, 34601

  • Forest Investigative Site 1090

    Broomall, Pennsylvania, 19008

  • Forest Investigative Site 1244

    Bryan, Texas, 77802

  • Forest Investigative Site 1063

    Buena Park, California, 90620

  • Forest Investigative Site 1151

    Buffalo, New York, 14215

  • Forest Investigative Site 1743

    Burbank, California, 91505

  • Forest Investigative Site 1020

    Burke, Virginia, 22015

  • Forest Investigative Site 1073

    Burlington, North Carolina, 27215

  • Forest Investigative Site 1210

    Canal Fulton, Ohio, 44614

  • Forest Investigative Site 1006

    Carmichael, California, 95608

  • Forest Investigative Site 1218

    Carnegie, Pennsylvania, 15106

  • Forest Investigative Site 1776

    Carrollton, Texas, 75006

  • Forest Investigative Site 1142

    Cary, North Carolina, 27519

  • Forest Investigative Site 1760

    Charleston, South Carolina, 29407

  • Forest Investigative Site 1363

    Charleston, South Carolina, 29412

  • Forest Investigative Site 1377

    Charleston, West Virginia, 25304

  • Forest Investigative Site 1733

    Charlotte, North Carolina, 28209

  • Forest Investigative Site 1067

    Charlotte, North Carolina, 28277

  • Forest Investigative Site 1037

    Chattanooga, Tennessee, 37421

  • Forest Investigative Site 1336

    Chelsea, Michigan, 48118

  • Forest Investigative Site 1747

    Chicago, Illinois, 60607

  • Forest Investigative Site 1071

    Chicago, Illinois, 60611

  • Forest Investigative Site 1752

    Chicago, Illinois, 60616

  • Forest Investigative Site 1384

    Chino, California, 91710

  • Forest Investigative Site 1190

    Chula Vista, California, 91911

  • Forest Investigative Site 1012

    Cincinnati, Ohio, 45219

  • Forest Investigative Site 1721

    Cincinnati, Ohio, 45219

  • Forest Investigative Site 1280

    Cincinnati, Ohio, 45224

  • Forest Investigative Site 1798

    Cincinnati, Ohio, 45227

  • Forest Investigative Site 1732

    Cincinnati, Ohio, 45236

  • Forest Investigative Site 1718

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 1062

    Cincinnati, Ohio, 45246

  • Forest Investigative Site 1050

    Cincinnati, Ohio, 45249

  • Forest Investigative Site 1031

    Clarksville, Tennessee, 37043

  • Forest Investigative Site 1764

    Clearwater, Florida, 33756

  • Forest Investigative Site 1084

    Cleveland, Ohio, 44122

  • Forest Investigative Site 1015

    Clinton, Utah, 84015

  • Forest Investigative Site 1074

    Collierville, Tennessee, 38107

  • Forest Investigative Site 1162

    Colorado Springs, Colorado, 80904

  • Forest Investigative Site 1122

    Columbia, South Carolina, 29204

  • Forest Investigative Site 1765

    Columbus, Ohio, 43213

  • Forest Investigative Site 1395

    Columbus, Ohio, 43214

  • Forest Investigative Site 1182

    Coral Gables, Florida, 33134

  • Forest Investigative Site 1249

    Coral Gables, Florida, 33134

  • Forest Investigative Site 1205

    Corpus Christi, Texas, 78404

  • Forest Investigative Site 1268

    Corsicana, Texas, 75110

  • Forest Investigative Site 1178

    Costa Mesa, California, 92626

  • Forest Investigative Site 1215

    Covington, Louisiana, 70433

  • Forest Investigative Site 1801

    Crestview Hills, Kentucky, 41017

  • Forest Investigative Site 1045

    Cromwell, Connecticut, 06416

  • Forest Investigative Site 1221

    Cutler Bay, Florida, 33189

  • Forest Investigative Site 1185

    Dakota Dunes, South Dakota, 57049

  • Forest Investigative Site 1213

    Dallas, Texas, 75235

  • Forest Investigative Site 1343

    Danville, Virginia, 24541

  • Forest Investigative Site 1793

    Daytona Beach, Florida, 32117

  • Forest Investigative Site 1266

    Deerfield Beach, Florida, 33441

  • Forest Investigative Site 1100

    DeFuniak Springs, Florida, 32435

  • Forest Investigative Site 1734

    DeLand, Florida, 32720

  • Forest Investigative Site 1209

    Delaware, Ohio, 43015

  • Forest Investigative Site 1270

    Denver, Colorado, 80209

  • Forest Investigative Site 1711

    Denver, Colorado, 80220

  • Forest Investigative Site 1043

    Diamond Bar, California, 91765

  • Forest Investigative Site 1775

    Doral, Florida, 33166

  • Forest Investigative Site 1378

    Doral, Florida, 33172

  • Forest Investigative Site 1163

    Downington, Pennsylvania, 19335

  • Forest Investigative Site 1187

    Draper, Utah, 84020

  • Forest Investigative Site 1226

    Draper, Utah, 84020

  • Forest Investigative Site 1342

    Dunn, North Carolina, 28334

  • Forest Investigative Site 1237

    Edgewater, Florida, 32132

  • Forest Investigative Site 1709

    Edison, New Jersey, 08817

  • Forest Investigative Site 1362

    Encinitas, California, 92024

  • Forest Investigative Site 1118

    Erie, Pennsylvania, 16508

  • Forest Investigative Site 1171

    Erie, Pennsylvania, 16509

  • Forest Investigative Site 1379

    Eugene, Oregon, 97402

  • Forest Investigative Site 1780

    Eugene, Oregon, 97404

  • Forest Investigative Site 1274

    Eunice, Louisiana, 70535

  • Forest Investigative Site 1091

    Evansville, Indiana, 47710

  • Forest Investigative Site 1103

    Evansville, Indiana, 47712

  • Forest Investigative Site 1033

    Fayetteville, Tennessee, 37334

  • Forest Investigative Site 1097

    Flint, Michigan, 48504

  • Forest Investigative Site 1047

    Foley, Alabama, 36535

  • Forest Investigative Site 1068

    Fort Lauderdale, Florida, 33306

  • Forest Investigative Site 1026

    Fort Lauderdale, Florida, 33308

  • Forest Investigative Site 1330

    Fort Lauderdale, Florida, 33319

  • Forest Investigative Site 1388

    Fremont, Nebraska, 68025-2300

  • Forest Investigative Site 1313

    Fremont, Nebraska, 68025

  • Forest Investigative Site 1144

    Fresno, California, 93721

  • Forest Investigative Site 1095

    Fresno, California, 93726

  • Forest Investigative Site 1794

    Gainsville, Florida, 32605

  • Forest Investigative Site 1710

    Garden Grove, California, 92844

  • Forest Investigative Site 1021

    Glen Falls, New York, 12801

  • Forest Investigative Site 1145

    Glendale, Arizona, 85308

  • Forest Investigative Site 1703

    Goodyear, Arizona, 85395

  • Forest Investigative Site 1022

    Greenbrae, California, 94904

  • Forest Investigative Site 1088

    Greensboro, North Carolina, 27401

  • Forest Investigative Site 1385

    Greensboro, North Carolina, 27408

  • Forest Investigative Site 1309

    Greensboro, North Carolina, 27410

  • Forest Investigative Site 1133

    Greenville, South Carolina, 29615

  • Forest Investigative Site 1809

    Greenville, South Carolina, 29615

  • Forest Investigative Site 1327

    Greer, South Carolina, 29651

  • Forest Investigative Site 1717

    Gulf Shores, Alabama, 36542

  • Forest Investigative Site 1132

    Haddon Heights, New Jersey, 08035

  • Forest Investigative Site 1261

    Hallandale, Florida, 33009

  • Forest Investigative Site 1726

    Haverhill, Massachusetts, 01830

  • Forest Investigative Site 1387

    Hayden Lake, Idaho, 83835

  • Forest Investigative Site 1403

    Hazel Crest, Illinois, 60429

  • Forest Investigative Site 1044

    Henderson, Nevada, 89014

  • Forest Investigative Site 1052

    Henderson, Nevada, 89052

  • Forest Investigative Site 1240

    Hialeah, Florida, 33012

  • Forest Investigative Site 1260

    Hialeah, Florida, 33012

  • Forest Investigative Site 1306

    Hickory, North Carolina, 28601

  • Forest Investigative Site 1098

    Hickory, North Carolina, 28602

  • Forest Investigative Site 1108

    Hillsboro, Oregon, 97123-4147

  • Forest Investigative Site 1383

    Holland, Pennsylvania, 18966

  • Forest Investigative Site 1155

    Hollywood, Florida, 33021

  • Forest Investigative Site 1018

    Honolulu, Hawaii, 96814

  • Forest Investigative Site 1228

    Houston, Texas, 77024

  • Forest Investigative Site 1372

    Houston, Texas, 77024

  • Forest Investigative Site 1777

    Houston, Texas, 77030

  • Forest Investigative Site 1157

    Houston, Texas, 77036

  • Forest Investigative Site 1360

    Houston, Texas, 77062

  • Forest Investigative Site 1230

    Houston, Texas, 77074

  • Forest Investigative Site 1774

    Houston, Texas, 77081

  • Forest Investigative Site 1370

    Huntington Beach, California, 92647

  • Forest Investigative Site 1704

    Huntington Park, California, 90255

  • Forest Investigative Site 1725

    Huntington Park, California, 90255

  • Forest Investigative Site 1345

    Hutchinson, Kansas, 67502

  • Forest Investigative Site 1061

    Hyannis, Massachusetts, 02601

  • Forest Investigative Site 1262

    Irving, Texas, 75039

  • Forest Investigative Site 1057

    Jackson, Mississippi, 39289-1214

  • Forest Investigative Site 1233

    Jacksonville, Florida, 32216

  • Forest Investigative Site 1253

    Jacksonville, Florida, 32216

  • Forest Investigative Site 1264

    Jacksonville, Florida, 32216

  • Forest Investigative Site 1256

    Jacksonville, Florida, 32223

  • Forest Investigative Site 1720

    Jenkintown, Pennsylvania, 19046

  • Forest Investigative Site 1077

    Jupiter, Florida, 33458

  • Forest Investigative Site 1165

    Kalamazoo, Michigan, 49009

  • Forest Investigative Site 1782

    Kansas City, Missouri, 64111

  • Forest Investigative Site 1763

    Kingsport, Tennessee, 37660

  • Forest Investigative Site 1041

    Kissimmee, Florida, 34741

  • Forest Investigative Site 1399

    Kissimmee, Florida, 34741

  • Forest Investigative Site 1744

    Knoxville, Tennessee, 37920

  • Forest Investigative Site 1742

    La Mesa, California, 91942

  • Forest Investigative Site 1207

    Lansdale, Pennsylvania, 19446

  • Forest Investigative Site 1011

    Las Vegas, Nevada, 89101

  • Forest Investigative Site 1376

    Las Vegas, Nevada, 89103

  • Forest Investigative Site 1019

    Las Vegas, Nevada, 89104

  • Forest Investigative Site 1807

    Las Vegas, Nevada, 89123

  • Forest Investigative Site 1048

    Las Vegas, Nevada, 89148

  • Forest Investigative Site 1805

    Lenexa, Kansas, 66219

  • Forest Investigative Site 1110

    Lenoir, North Carolina, 28645

  • Forest Investigative Site 1366

    Lexington, Kentucky, 40509

  • Forest Investigative Site 1236

    Lilburn, Georgia, 30047

  • Forest Investigative Site 1141

    Linden, New Jersey, 07036

  • Forest Investigative Site 1290

    Little Rock, Arkansas, 72204

  • Forest Investigative Site 1138

    Little Rock, Arkansas, 72211

  • Forest Investigative Site 1381

    Lomita, California, 90717

  • Forest Investigative Site 1706

    Long Beach, California, 90806

  • Forest Investigative Site 1229

    Longview, Texas, 75605

  • Forest Investigative Site 1248

    Los Angelas, California, 90057

  • Forest Investigative Site 1785

    Los Angelas, California, 90057

  • Forest Investigative Site 1029

    Los Angeles, California, 90017

  • Forest Investigative Site 1361

    Los Angeles, California, 90017

  • Forest Investigative Site 1102

    Los Angeles, California, 90036

  • Forest Investigative Site 1770

    Louisville, Kentucky, 40213

  • Forest Investigative Site 1128

    Lutherville, Maryland, 21093

  • Forest Investigative Site 1201

    Lyndhurst, Ohio, 44124

  • Forest Investigative Site 1177

    Madisonville, Kentucky, 42431

  • Forest Investigative Site 1086

    Magna, Utah, 84044

  • Forest Investigative Site 1164

    Manassas, Virginia, 20110

  • Forest Investigative Site 1389

    Marietta, Georgia, 30060

  • Forest Investigative Site 1002

    Marietta, Georgia, 30066

  • Forest Investigative Site 1246

    Maumee, Ohio, 43537

  • Forest Investigative Site 1358

    Memphis, Tennessee, 38119

  • Forest Investigative Site 1082

    Memphis, Tennessee, 38125

  • Forest Investigative Site 1004

    Meridian, Idaho, 83646

  • Forest Investigative Site 1757

    Mesa, Arizona, 85202

  • Forest Investigative Site 1323

    Metairie, Louisiana, 70006

  • Forest Investigative Site 1795

    Metairie, Louisiana, 77002

  • Forest Investigative Site 1784

    Miami, Florida, 33014

  • Forest Investigative Site 1364

    Miami, Florida, 33125

  • Forest Investigative Site 1206

    Miami, Florida, 33135

  • Forest Investigative Site 1397

    Miami, Florida, 33136

  • Forest Investigative Site 1180

    Miami, Florida, 33143

  • Forest Investigative Site 1396

    Miami, Florida, 33144

  • Forest Investigative Site 1154

    Miami, Florida, 33155

  • Forest Investigative Site 1788

    Miami, Florida, 33169

  • Forest Investigative Site 1223

    Miami, Florida, 33183

  • Forest Investigative Site 1707

    Miami, Florida, 33185

  • Forest Investigative Site 1282

    Miami, Florida, 33186

  • Forest Investigative Site 1297

    Miami Springs, Florida, 33166

  • Forest Investigative Site 1367

    Milwaukee, Wisconsin, 53215

  • Forest Investigative Site 1255

    Mission, Kansas, 66202

  • Forest Investigative Site 1054

    Mission Hills, California, 91345

  • Forest Investigative Site 1326

    Missoula, Montana, 59808

  • Forest Investigative Site 1056

    Mobile, Alabama, 36617

  • Forest Investigative Site 1272

    Mooresville, North Carolina, 28117

  • Forest Investigative Site 1386

    Moreno Valley, California, 92553

  • Forest Investigative Site 1126

    Morton, Illinois, 61550

  • Forest Investigative Site 1135

    Mount Gilead, Ohio, 43338

  • Forest Investigative Site 1127

    Mt. Pleasant, South Carolina, 29464

  • Forest Investigative Site 1147

    Muncie, Indiana, 47304

  • Forest Investigative Site 1310

    Murrells Inlet, South Carolina, 29576

  • Forest Investigative Site 1719

    Muscle Shoals, Alabama, 35662

  • Forest Investigative Site 1039

    Nampa, Idaho, 83686

  • Forest Investigative Site 1199

    New Braunfels, Texas, 78130

  • Forest Investigative Site 1285

    New Orleans, Louisiana, 70115

  • Forest Investigative Site 1779

    New Orleans, Louisiana, 70119

  • Forest Investigative Site 1708

    New Port Richey, Florida, 34652

  • Forest Investigative Site 1756

    Newport Beach, California, 92663

  • Forest Investigative Site 1092

    Newton, Kansas, 67114

  • Forest Investigative Site 1767

    Norfolk, Virginia, 23510

  • Forest Investigative Site 1195

    Norman, Oklahoma, 73069

  • Forest Investigative Site 1314

    Norristown, Pennsylvania, 19401

  • Forest Investigative Site 1728

    North Dartmouth, Massachusetts, 02747

  • Forest Investigative Site 1176

    North Miami Beach, Florida, 33162

  • Forest Investigative Site 1013

    Northglenn, Colorado, 80234

  • Forest Investigative Site 1181

    Northridge, California, 91325

  • Forest Investigative Site 1283

    O'Fallon, Illinois, 62269

  • Forest Investigative Site 1390

    Oakwood, Georgia, 30566

  • Forest Investigative Site 1216

    Ogden, Utah, 84405

  • Forest Investigative Site 1184

    Oklahoma City, Oklahoma, 73103

  • Forest Investigative Site 1305

    Oklahoma City, Oklahoma, 73103

  • Forest Investigative Site 1759

    Oklahoma City, Oklahoma, 73103

  • Forest Investigative Site 1284

    Oldsmar, Florida, 34677

  • Forest Investigative Site 1034

    Olive Branch, Mississippi, 38654

  • Forest Investigative Site 1035

    Omaha, Nebraska, 68114

  • Forest Investigative Site 1016

    Omaha, Nebraska, 68134

  • Forest Investigative Site 1254

    Omaha, Nebraska, 68134

  • Forest Investigative Site 1148

    Omaha, Nebraska, 68144

  • Forest Investigative Site 1232

    Opa-locka, Florida, 33054

  • Forest Investigative Site 1212

    Orange, California, 92868

  • Forest Investigative Site 1219

    Orem, Utah, 84058

  • Forest Investigative Site 1802

    Orlando, Florida, 32806

  • Forest Investigative Site 1049

    Orlando, Florida, 32811

  • Forest Investigative Site 1235

    Orlando, Florida, 32822

  • Forest Investigative Site 1741

    Ormond Beach, Florida, 32174

  • Forest Investigative Site 1003

    Oviedo, Florida, 32765

  • Forest Investigative Site 1369

    Palm Harbor, Florida, 34684

  • Forest Investigative Site 1101

    Palm Springs, California, 92262

  • Forest Investigative Site 1014

    Paramount, California, 90723

  • Forest Investigative Site 1227

    Paramus, New Jersey, 07652

  • Forest Investigative Site 1152

    Pelzer, South Carolina, 29669

  • Forest Investigative Site 1079

    Pembroke Pines, Florida, 33024

  • Forest Investigative Site 1053

    Pembroke Pines, Florida, 33026

  • Forest Investigative Site 1055

    Pembroke Pines, Florida, 33028

  • Forest Investigative Site 1161

    Pembroke Pines, Florida, 33028

  • Forest Investigative Site 1166

    Pembroke Pines, Florida, 33028

  • Forest Investigative Site 1224

    Pembroke Pines, Florida, 33028

  • Forest Investigative Site 1075

    Pembroke Pines, Florida, 33029

  • Forest Investigative Site 1198

    Penndel, Pennsylvania, 19047

  • Forest Investigative Site 1322

    Perrysburg, Ohio, 43551

  • Forest Investigative Site 1292

    Petersburg, Virginia, 23803

  • Forest Investigative Site 1293

    Philadelphia, Pennsylvania, 19152

  • Forest Investigative Site 1170

    Phoenix, Arizona, 85015

  • Forest Investigative Site 1238

    Phoenix, Arizona, 85018

  • Forest Investigative Site 1204

    Phoenix, Arizona, 85020

  • Forest Investigative Site 1755

    Phoenix, Arizona, 85020

  • Forest Investigative Site 1259

    Phoenix, Arizona, 85032

  • Forest Investigative Site 1001

    Phoenix, Arizona, 85050

  • Forest Investigative Site 1271

    Picayune, Mississippi, 39466

  • Forest Investigative Site 1371

    Pine Bluff, Arkansas, 71603

Other trials in United States

About this study

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

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.

Being tested
Nebivolol and Valsartan 1, Nebivolol and Valsartan 2, Nebivolol and Valsartan 3, Nebivolol 1, Nebivolol 2
Keywords
Stage 1, Stage 2, Hypertension
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nebivolol and Valsartan 1Drug

    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

  • Nebivolol and Valsartan 2Drug

    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

  • Nebivolol and Valsartan 3Drug

    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 1Drug

    Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration

  • Nebivolol 2Drug

    Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration

  • Valsartan 1Drug

    Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration

  • Valsartan 2Drug

    Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration

  • PlaceboDrug

    Dose matched placebo, oral administration

Study groups in NCT01508026
Study groupRoleWhat they receive
Nebivolol and Valsartan Fixed Dose Combination 1ExperimentalFixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg
Receives: Drug: Nebivolol and Valsartan 1
Nebivolol and Valsartan Fixed Dose Combination 2ExperimentalFixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg
Receives: Drug: Nebivolol and Valsartan 2
Nebivolol and Valsartan Fixed Dose Combination 3ExperimentalFixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg
Receives: Drug: Nebivolol and Valsartan 3
Nebivolol Low DoseExperimentalNebivolol Monotherapy 5 mg
Receives: Drug: Nebivolol 1
Nebivolol High DoseExperimentalNebivolol Monotherapy 20 mg
Receives: Drug: Nebivolol 2
Valsartan Low DoseExperimentalValsartan Monotherapy 80 mg
Receives: Drug: Valsartan 1
Valsartan High DoseExperimentalValsartan Monotherapy 160 mg
Receives: Drug: Valsartan 2
PlaceboPlacebo comparatorDose Matched placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Sitting Diastolic Blood Pressure (DBP)

    Measured: from basline to Week 8

Secondary outcomes (1)

  1. Change in Sitting Systolic Blood Pressure (SBP)

    Measured: from baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
4,161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01508026
Sponsor's protocol ID
NAC-MD-01
Status last verified
Mar 2014
First submitted
9 Jan 2012
Last updated
25 Apr 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 24881993

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nebivolol and Valsartan 1, Nebivolol and Valsartan 2 and Nebivolol and Valsartan 3 in people with Stage 1 Hypertension and Stage 2 Hypertension, run by Forest Laboratories at 413 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 413 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sitting Diastolic Blood Pressure (DBP) (time frame: from basline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01508026, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.

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