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


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Hypertension

High Blood Pressure; Hypertension/High Blood Pressure


Clinical Trial: Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans

This study is currently recruiting patients.
Verified by Mylan Bertek Pharmaceuticals September 2005

Sponsored by: Mylan Bertek Pharmaceuticals
Information provided by: Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00145210

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 III

MedlinePlus related topics:  High Blood Pressure

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Blood pressure; Heart Rate
Secondary Outcomes: Safety and tolerability
Expected Total Enrollment:  630

Study start: April 2005

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00145210

Will A Sullivan, BS      304-554-6587    Will.Sullivan@mylanlabs.com
P J Guyton, BS      304-599-2595  Ext. 6693 

West Virginia
      Mylan Pharmaceuticals Inc., Morgantown,  West Virginia,  26505,  United States; Recruiting
Will A. Sullivan, BS  304-554-6587    Will.Sullivan@mylanlabs.com 
P J Guyton, BS  304-599-2595  Ext. 6693    PJ.Guyton@mylanlabs.com 
Multi-Center,  Principal Investigator

Study chairs or principal investigators

Betty S. Riggs, MD, MBA,  Study Director,  Mylan Pharmaceuticals Inc.   

More Information

Study ID Numbers:  NEB310
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145210
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06


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Page Updated: December 9, 2005
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