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

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ClinicalTrials.gov Identifier: NCT00145210
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : March 7, 2008
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol and Atenolol Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo- and Active-Controlled, Forced Titration Study Evaluating the Effects of Nebivolol on Blood Pressure and Heart Rate in African American Patients With Hypertension
Study Start Date : April 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure
  2. Heart Rate

Secondary Outcome Measures :
  1. Safety and tolerability

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145210


Locations
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United States, West Virginia
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
Investigators
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Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00145210    
Other Study ID Numbers: NEB310
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: September 2005
Keywords provided by Mylan Bertek Pharmaceuticals:
Nebivolol
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Nebivolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists