- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00200460
A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients
September 12, 2005 updated by: Mylan Bertek Pharmaceuticals
A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension
The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.
Study Overview
Detailed Description
This was a multi-center, 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 followed by randomization/double-blind treatment.
During the double-blind phase, patients received nebivolol or placebo.
Patients had 7 scheduled clinical visits during the study.
Study Type
Interventional
Enrollment
825
Phase
- Phase 3
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 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 treatment or discontinuation of current antihypertensive therapy
- Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception
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 change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline
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Secondary Outcome Measures
Outcome Measure |
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- Response rate
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- Sitting SBP
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- Supine SBP and DBP
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- Standing SBP and DBP
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- Correlation between plasma levels
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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
September 1, 2001
Study Completion
March 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)
September 20, 2005
Last Update Submitted That Met QC Criteria
September 12, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic beta-1 Receptor Agonists
- Nebivolol
Other Study ID Numbers
- NEB302
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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