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

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 III

MedlinePlus related topics:

High Blood Pressure

Drug Information available for:

Nebivolol

U.S. FDA Resources

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

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.

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
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

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

Study ID Numbers:	NEB202
First Received:	September 1, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00145236
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mylan Bertek Pharmaceuticals:

Nebivolol

Beta-Blocker

Study placed in the following topic categories:

Vascular Diseases

Nebivolol

Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adrenergic beta-Antagonists

Adrenergic Antagonists

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Mylan Bertek Pharmaceuticals
Information provided by:	Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00145236