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

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.
 
ClinicalTrials.gov Identifier: NCT00145236
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 14, 2005
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Phase 3

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : November 2001
Study Completion Date : August 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. -Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline

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

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

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
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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): NCT00145236


Locations
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United States, West Virginia
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
Investigators
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Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00145236    
Other Study ID Numbers: NEB202
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005
Keywords provided by Mylan Bertek Pharmaceuticals:
Nebivolol
Beta-Blocker
Additional relevant MeSH terms:
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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