We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00200460
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mylan Bertek Pharmaceuticals
  Purpose
The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.

Condition Intervention Phase
Hypertension Drug: Nebivolol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Mylan Bertek Pharmaceuticals:

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

Secondary Outcome Measures:
  • - Sitting SBP
  • - Supine SBP and DBP
  • - Standing SBP and DBP
  • - Response rate
  • - Correlation between plasma levels

Estimated Enrollment: 825
Study Start Date: September 2001
Estimated Study Completion Date: March 2003
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200460


Locations
United States, West Virginia
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
Investigators
Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00200460     History of Changes
Other Study ID Numbers: NEB302
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Mylan Bertek Pharmaceuticals:
Nebivolol
Hypertension
Beta-Blocker

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


To Top