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A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients

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: NCT00200473
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals

Brief Summary:
A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Phase 3

Detailed Description:
This study was a multi-center, multi-national, 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 and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Effects of Nebivolol on Safety and Efficacy in Patients With Mild to Moderate Hypertension
Study Start Date : September 2001
Study Completion Date : March 2003

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The change of the average sitting diastolic blood pressure (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline

Secondary Outcome Measures :
  1. - The change of the average sitting, supine and standing systolic and diastolic blood pressure at trough and peak at end of treatment compared to baseline
  2. - Response rate


Information from the National Library of Medicine

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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:

  • 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 therapy or discontinuation of prior antihypertensive agents
  • Pregnancy, nursing or women of childbearing age not using appropriate contraception

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): NCT00200473


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
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ClinicalTrials.gov Identifier: NCT00200473    
Other Study ID Numbers: NEB305
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: September 2005
Keywords provided by Mylan Bertek Pharmaceuticals:
Nebivolol
Hypertension
Beta-Blockers
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