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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

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 5, 2005
Last Update Posted Date September 14, 2005
Study Start Date  ICMJE November 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
-Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
To determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • -Change in sitting systolic blood pressure (SBP)
  • -Change in supine and standing DBP and SBP
  • -Response rate
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
To determine, over a broad range of beta-blockers doses, the dose-response relationship of nebivolol on blood pressure in Black patients with mild to moderate hypertension
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension
Official Title  ICMJE 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.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Nebivolol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 1, 2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00145236
Other Study ID Numbers  ICMJE NEB202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Mylan Bertek Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
PRS Account Mylan Bertek Pharmaceuticals
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP