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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT01508026•Forest Laboratories

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

Locations (413)

Forest Investigative Site 1750

Birmingham, Alabama, United States

Forest Investigative Site 1038

Birmingham, Alabama, United States

Forest Investigative Site 1308

Birmingham, Alabama, United States

Forest Investigative Site 1192

Birmingham, Alabama, United States

Forest Investigative Site 1005

Birmingham, Alabama, United States

Forest Investigative Site 1047

Foley, Alabama, United States

Forest Investigative Site 1717

Gulf Shores, Alabama, United States

Forest Investigative Site 1056

Mobile, Alabama, United States

Forest Investigative Site 1719

Muscle Shoals, Alabama, United States

Forest Investigative Site 1145

Glendale, Arizona, United States

Key Dates

Start Date

January 1, 2012

Primary Completion Date

March 1, 2013

Completion Date

May 1, 2013

Last Updated

April 25, 2014

Enrollment

4,161

ACTUAL participants

Conditions

Stage 1 HypertensionStage 2 Hypertension

Interventions

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

DRUG

Sponsors

Lead Sponsor

Forest Laboratories

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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