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Completed

NCT Number: NCT00200460

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, 26505, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebivolol

Drug

Primary outcomes

  1. 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

  1. - Sitting SBP

  2. - Supine SBP and DBP

  3. - Standing SBP and DBP

  4. - Response rate

  5. - Correlation between plasma levels

Sponsors and collaborators

Lead sponsor

Mylan Bertek Pharmaceuticals

Industry

Registry information

Official study title

A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension

Important dates

Study start
2001
Study completion
2003
First posted
Sep 20, 2005
Registry last updated
Sep 20, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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