Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension

This study has been completed.
Information provided by:
Mylan Bertek Pharmaceuticals Identifier:
First received: September 1, 2005
Last updated: September 12, 2005
Last verified: September 2005
The purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.

Condition Intervention Phase
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, Multicenter, Randomized, Placebo-Controlled, Parallel Group Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension.

Resource links provided by NLM:

Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:
  • -Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline

Secondary Outcome Measures:
  • -Change in sitting systolic blood pressure (SBP)
  • -Change in supine and standing DBP and SBP
  • -Response rate

Estimated Enrollment: 300
Study Start Date: November 2001
Estimated Study Completion Date: August 2003
Detailed Description:
This study was a Phase II, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in Black patients with mild to moderate hypertension. Treatment was administered once daily (qd) for 12 weeks. The study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. Patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Black adults with 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
  • Contraindication to beta-blocker therapy
  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 identifier: NCT00145236

United States, West Virginia
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
  More Information Identifier: NCT00145236     History of Changes
Other Study ID Numbers: NEB202 
Study First Received: September 1, 2005
Last Updated: September 12, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Mylan Bertek Pharmaceuticals:

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Vasodilator Agents processed this record on May 30, 2016