- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00200499
A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients
December 15, 2005 updated by: Mylan Bertek Pharmaceuticals
A Multi-Center, Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients With Mild to Moderate Hypertension
The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension.
This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305.
Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.
Study Overview
Detailed Description
This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated, based on entry into NEB 202, NEB 302 or NEB 305).
Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist.
After successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study.
Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.
Study Type
Interventional
Enrollment
845
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:
- To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.
Exclusion Criteria:
- Secondary hypertension
- myocardial infarction or stroke
- contraindications to beta-blocker 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: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.
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Secondary Outcome Measures
Outcome Measure |
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Change in the average
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- sitting systolic blood pressure
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- supine and standing systolic and diastolic blood pressure
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- response rate of treatment groups
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- AEs
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- ECGs
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- laboratory parameters
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- heart rate
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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
March 1, 2002
Study Completion
September 1, 2003
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 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
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
- NEB306
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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