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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145210
First Posted: September 5, 2005
Last Update Posted: March 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mylan Bertek Pharmaceuticals
  Purpose
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 Intervention Phase
Hypertension Drug: Nebivolol and Atenolol Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:
  • Blood pressure
  • Heart Rate

Secondary Outcome Measures:
  • Safety and tolerability

Estimated Enrollment: 630
Study Start Date: April 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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
United States, West Virginia
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
Investigators
Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00145210     History of Changes
Other Study ID Numbers: NEB310
First Submitted: September 1, 2005
First Posted: September 5, 2005
Last Update Posted: March 7, 2008
Last Verified: September 2005

Keywords provided by Mylan Bertek Pharmaceuticals:
Nebivolol

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Atenolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists