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

Mylan Bertek Pharmaceuticals300 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Hypertension

Interventions

NebivololDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

-Change in sitting systolic blood pressure (SBP)

-Change in supine and standing DBP and SBP

-Response rate

Data from ClinicalTrials.gov

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