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

Stage 1 Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508026
• Other study ID #: NAC-MD-01
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2012
• Last updated: March 28, 2014
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4161
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female outpatients of age 18 years or above

• Patients diagnosed with stage 1 or stage 2 essential hypertension

• Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

• Secondary hypertension or severe hypertension

• Clinically significant cardiovascular disease or heart failure

• Clinical significant respiratory disease that would prohibit the use of a beta blocker

• A medical contraindication to discontinuing a current antihypertensive therapy

• History of Type 1 diabetes mellitus

• History of Severe Mental Illness except mild depression

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Stage 1 Hypertension
• Stage 2 Hypertension

Intervention

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
• 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
• 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
• Nebivolol 1
Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
• Nebivolol 2
Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
• Valsartan 1
Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
• Valsartan 2
Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
• Placebo
Dose matched placebo, oral administration

Locations

Country	Name	City	State
United States	Forest Investigative Site 1790	Addison	Illinois
United States	Forest Investigative Site 1203	Akron	Ohio
United States	Forest Investigative Site 1761	Albuquerque	New Mexico
United States	Forest Investigative Site 1094	Arlington	Texas
United States	Forest Investigative Site 1130	Arlington	Virginia
United States	Forest Investigative Site 1786	Arlington	Virginia
United States	Forest Investigative Site 1093	Arlington Heights	Illinois
United States	Forest Investigative Site 1040	Asheboro	North Carolina
United States	Forest Investigative Site 1116	Ashland	Oregon
United States	Forest Investigative Site 1281	Atlanta	Georgia
United States	Forest Investigative Site 1745	Atlanta	Georgia
United States	Forest Investigative Site 1769	Auburn	Maine
United States	Forest Investigative Site 1107	Augusta	Kansas
United States	Forest Investigative Site 1245	Austin	Texas
United States	Forest Investigative Site 1311	Austin	Texas
United States	Forest Investigative Site 1125	Baltimore	Maryland
United States	Forest Investigative Site 1263	Baltimore	Maryland
United States	Forest Investigative Site 1251	Baton Rouge	Louisiana
United States	Forest Investigative Site 1174	Beaumont	Texas
United States	Forest Investigative Site 1028	Bellevue	Nebraska
United States	Forest Investigative Site 1025	Belzoni	Mississippi
United States	Forest Investigative Site 1109	Bensalem	Pennsylvania
United States	Forest Investigative Site 1291	Bensalem	Pennsylvania
United States	Forest Investigative Site 1005	Birmingham	Alabama
United States	Forest Investigative Site 1038	Birmingham	Alabama
United States	Forest Investigative Site 1192	Birmingham	Alabama
United States	Forest Investigative Site 1308	Birmingham	Alabama
United States	Forest Investigative Site 1750	Birmingham	Alabama
United States	Forest Investigative Site 1398	Blackfoot	Idaho
United States	Forest Investigative Site 1080	Blue Ridge	Georgia
United States	Forest Investigative Site 1159	Boca Raton	Florida
United States	Forest Investigative Site 1762	Boerne	Texas
United States	Forest Investigative Site 1727	Boise	Idaho
United States	Forest Investigative Site 1007	Bradenton	Florida
United States	Forest Investigative Site 1042	Brandon	Florida
United States	Forest Investigative Site 1324	Bridgeport	Connecticut
United States	Forest Investigative Site 1402	Bristol	Tennessee
United States	Forest Investigative Site 1796	Brooklyn	New York
United States	Forest Investigative Site 1702	Brooksville	Florida
United States	Forest Investigative Site 1090	Broomall	Pennsylvania
United States	Forest Investigative Site 1244	Bryan	Texas
United States	Forest Investigative Site 1063	Buena Park	California
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United States	Forest Investigative Site 1743	Burbank	California
United States	Forest Investigative Site 1020	Burke	Virginia
United States	Forest Investigative Site 1073	Burlington	North Carolina
United States	Forest Investigative Site 1210	Canal Fulton	Ohio
United States	Forest Investigative Site 1006	Carmichael	California
United States	Forest Investigative Site 1218	Carnegie	Pennsylvania
United States	Forest Investigative Site 1776	Carrollton	Texas
United States	Forest Investigative Site 1142	Cary	North Carolina
United States	Forest Investigative Site 1363	Charleston	South Carolina
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United States	Forest Investigative Site 1760	Charleston	South Carolina
United States	Forest Investigative Site 1067	Charlotte	North Carolina
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United States	Forest Investigative Site 1037	Chattanooga	Tennessee
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United States	Forest Investigative Site 1752	Chicago	Illinois
United States	Forest Investigative Site 1384	Chino	California
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United States	Forest Investigative Site 1061	Hyannis	Massachusetts
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United States	Forest Investigative Site 1253	Jacksonville	Florida
United States	Forest Investigative Site 1256	Jacksonville	Florida
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United States	Forest Investigative Site 1048	Las Vegas	Nevada
United States	Forest Investigative Site 1376	Las Vegas	Nevada
United States	Forest Investigative Site 1807	Las Vegas	Nevada
United States	Forest Investigative Site 1805	Lenexa	Kansas
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United States	Forest Investigative Site 1236	Lilburn	Georgia
United States	Forest Investigative Site 1141	Linden	New Jersey
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United States	Forest Investigative Site 1290	Little Rock	Arkansas
United States	Forest Investigative Site 1381	Lomita	California
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United States	Forest Investigative Site 1128	Lutherville	Maryland
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United States	Forest Investigative Site 1177	Madisonville	Kentucky
United States	Forest Investigative Site 1086	Magna	Utah
United States	Forest Investigative Site 1164	Manassas	Virginia
United States	Forest Investigative Site 1002	Marietta	Georgia
United States	Forest Investigative Site 1389	Marietta	Georgia
United States	Forest Investigative Site 1246	Maumee	Ohio
United States	Forest Investigative Site 1082	Memphis	Tennessee
United States	Forest Investigative Site 1358	Memphis	Tennessee
United States	Forest Investigative Site 1004	Meridian	Idaho
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United States	Forest Investigative Site 1323	Metairie	Louisiana
United States	Forest Investigative Site 1795	Metairie	Louisiana
United States	Forest Investigative Site 1154	Miami	Florida
United States	Forest Investigative Site 1180	Miami	Florida
United States	Forest Investigative Site 1206	Miami	Florida
United States	Forest Investigative Site 1223	Miami	Florida
United States	Forest Investigative Site 1282	Miami	Florida
United States	Forest Investigative Site 1364	Miami	Florida
United States	Forest Investigative Site 1396	Miami	Florida
United States	Forest Investigative Site 1397	Miami	Florida
United States	Forest Investigative Site 1707	Miami	Florida
United States	Forest Investigative Site 1784	Miami	Florida
United States	Forest Investigative Site 1788	Miami	Florida
United States	Forest Investigative Site 1297	Miami Springs	Florida
United States	Forest Investigative Site 1367	Milwaukee	Wisconsin
United States	Forest Investigative Site 1255	Mission	Kansas
United States	Forest Investigative Site 1054	Mission Hills	California
United States	Forest Investigative Site 1326	Missoula	Montana
United States	Forest Investigative Site 1056	Mobile	Alabama
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United States	Forest Investigative Site 1166	Pembroke Pines	Florida
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United States	Forest Investigative Site 1338	Union	New Jersey
United States	Forest Investigative Site 1806	Union	South Carolina
United States	Forest Investigative Site 1196	Upper St. Clair	Pennsylvania
United States	Forest Investigative Site 1099	Virginia Beach	Virginia
United States	Forest Investigative Site 1349	Waco	Texas
United States	Forest Investigative Site 1335	Walla Walla	Washington
United States	Forest Investigative Site 1172	Warminster	Pennsylvania
United States	Forest Investigative Site 1375	Warwick	Rhode Island
United States	Forest Investigative Site 1072	Waterbury	Connecticut
United States	Forest Investigative Site 1356	Watertown	Massachusetts
United States	Forest Investigative Site 1278	West Chester	Pennsylvania
United States	Forest Investigative Site 1783	Westlake Village	California
United States	Forest Investigative Site 1231	Willoughby	Ohio
United States	Forest Investigative Site 1081	Wilmington	North Carolina
United States	Forest Investigative Site 1705	Wilmington	North Carolina
United States	Forest Investigative Site 1319	Winston-Salem	North Carolina
United States	Forest Investigative Site 1405	Winston-Salem	North Carolina
United States	Forest Investigative Site 1778	Winston-Salem	North Carolina
United States	Forest Investigative Site 1120	Winter Haven	Florida
United States	Forest Investigative Site 1173	Woodstock	Georgia
United States	Forest Investigative Site 1392	Yukon	Oklahoma
United States	Forest Investigative Site 1713	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sitting Diastolic Blood Pressure (DBP)		from basline to Week 8	No
Secondary	Change in Sitting Systolic Blood Pressure (SBP)		from baseline to Week 8	No