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:


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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014