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

This study has been completed.
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00200460
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00200460     History of Changes
Other Study ID Numbers: NEB302
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 23, 2013