Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension

This study has been completed.

Sponsor:

Information provided by:

Mylan Bertek Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00145236

First received: September 1, 2005

Last updated: September 12, 2005

Last verified: September 2005

History of Changes

Purpose

The purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Nebivolol	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, Multicenter, Randomized, Placebo-Controlled, Parallel Group Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension.

Resource links provided by NLM:

MedlinePlus related topics: African American Health

Drug Information available for: Nebivolol Nebivolol Hydrochloride

U.S. FDA Resources

Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:

-Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline

Secondary Outcome Measures:

-Change in sitting systolic blood pressure (SBP)
-Change in supine and standing DBP and SBP
-Response rate


Estimated Enrollment:	300
Study Start Date:	November 2001
Estimated Study Completion Date:	August 2003

Detailed Description:

This study was a Phase II, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in Black patients with mild to moderate hypertension. Treatment was administered once daily (qd) for 12 weeks. The study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. Patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Black adults with an average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline.

Exclusion Criteria:

Recent myocardial infarction or stroke
Contraindication to beta-blocker 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: NCT00145236

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:	NCT00145236 History of Changes
Other Study ID Numbers:	NEB202
Study First Received:	September 1, 2005
Last Updated:	September 12, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mylan Bertek Pharmaceuticals:


Nebivolol Beta-Blocker

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Nebivolol 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

ClinicalTrials.gov processed this record on September 23, 2016

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