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

This study has been completed.

Sponsor:

Information provided by:

Mylan Bertek Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00145210

First received: September 1, 2005

Last updated: March 6, 2008

Last verified: September 2005

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

MedlinePlus related topics: African American Health

Drug Information available for: Atenolol Nebivolol Nebivolol Hydrochloride

U.S. FDA Resources

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	September 1, 2005
Last Updated:	March 6, 2008
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2016

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