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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2003-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Hypertension

Keywords

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Nebivolol Beta-Blocker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nebivolol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Betty S. Riggs, MD, MBA

Role: STUDY_DIRECTOR

Mylan Pharmaceuticals Inc

Locations

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Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NEB202

Identifier Type: -

Identifier Source: org_study_id