Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans

NCT ID: NCT00145210

Last Updated: 2008-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-09-30

Brief Summary

The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.

Detailed Description

Despite the established benefits of beta-blockers, their use is limited by their side effect profile and by a perception of reduced efficacy in certain populations such as African Americans (Amudha, 2003). This is a double-blind, randomized, placebo and active-controlled, multi-center, parallel group, forced titration study. Patients will be stratified across all treatment arms by age, gender, and diabetes status (history of diabetes mellitus vs no history of diabetes mellitus). The study consists of 3 periods: screening run-in, double-blind, randomized, forced titration and double-blind, washout period (only for patients who complete the double-blind, forced titration period and who are not participating in the long-term follow-up study). After a 14-28 day, single-blind, placebo controlled, run-in period, which includes washout (if applicable), eligible patients will be randomized to one of 3 treatment regimens for approximately 12 weeks.

This study will test the safety and efficacy of Nebivolol in the treatment of African American patients with hypertension.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Nebivolol and Atenolol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• African Americans with stage 1-2 hypertension

Exclusion Criteria

• Recent myocardial infarction or stroke
• Contraindications to beta-blocker therapy or stopping prior antihypertensive therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan Bertek Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Betty S. Riggs, MD, MBA

Role: STUDY_DIRECTOR

Mylan Pharmaceuticals Inc

Locations

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

NEB310

Identifier Type: -

Identifier Source: org_study_id