A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients

Phase 3CompletedNCT00200460

Mylan Bertek Pharmaceuticals825 enrolled

Overview

The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.

This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

825

Conditions

Hypertension

Interventions

NebivololDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Secondary hypertension * Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy * Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception

Locations (1)

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline

Secondary Outcomes

- Sitting SBP

- Supine SBP and DBP

- Standing SBP and DBP

- Response rate

- Correlation between plasma levels

Data from ClinicalTrials.gov

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