- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00200421
A Pilot Study Comparing Nebivolol and Atenolol and Its Effects With Exercise in Patients With Mild to Moderate Hypertension
December 15, 2005 updated by: Mylan Bertek Pharmaceuticals
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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West Virginia
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Morgantown, West Virginia, United States, 26505
- Mylan Pharmaceuticals Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.
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Secondary Outcome Measures
Outcome Measure |
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The change in sub-maximal exercise duration at end of treatment compared to baseline.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Betty S. Riggs, MD, MBA, Mylan Pharmaceuticals Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Study Completion
August 1, 2003
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
December 16, 2005
Last Update Submitted That Met QC Criteria
December 15, 2005
Last Verified
August 1, 2003
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Adrenergic beta-1 Receptor Agonists
- Nebivolol
- Atenolol
Other Study ID Numbers
- NEB203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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