A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients

Phase 3CompletedNCT00200473

Mylan Bertek Pharmaceuticals800 enrolled

Overview

A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

This study was a multi-center, multi-national, 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 and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

800

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 therapy or discontinuation of prior antihypertensive agents * Pregnancy, nursing or women of childbearing age 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 (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline

Secondary Outcomes

- The change of the average sitting, supine and standing systolic and diastolic blood pressure at trough and peak at end of treatment compared to baseline

- Response rate

Data from ClinicalTrials.gov

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