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A Pilot Study Comparing Nebivolol and Atenolol and Its Effects With Exercise in Patients With Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00200421
First received: September 12, 2005
Last updated: December 15, 2005
Last verified: August 2003

September 12, 2005
December 15, 2005
May 2002
Not Provided
The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.
Same as current
Complete list of historical versions of study NCT00200421 on ClinicalTrials.gov Archive Site
The change in sub-maximal exercise duration at end of treatment compared to baseline.
Same as current
Not Provided
Not Provided
 
A Pilot Study Comparing Nebivolol and Atenolol and Its Effects With Exercise in Patients With Mild to Moderate Hypertension
A Double-Blind, Randomized, Multi-Center, Active Comparator, Five Treatment Study of the Effects of Nebivolol Compared to Atenolol on Cardiovascular Hemodynamics and Exercise Capacity in Patients With Mild to Moderate Hypertension

The purpose of this study is to determine the effects on exercise capacity of nebivolol compared to atenolol in hypertensive patients.

This was a pilot, phase II, double-blind, randomized, muticenter, active-comparator, five treatment parallel group dosing and mechanistic study. The study consisted of two phases: 1) screen/washout/single-blind placebo run-in and 2) randomization/treatment. There was a minimum of five scheduled study visits.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: Nebivolol and Atenolol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
August 2003
Not Provided

Inclusion Criteria:

  • An average sitting diastolic blood pressure (DBP) 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 stopping prior antihypertensive therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200421
NEB203
Not Provided
Not Provided
Mylan Bertek Pharmaceuticals
Not Provided
Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
Mylan Bertek Pharmaceuticals
August 2003

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