- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00200434
A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension
September 12, 2005 updated by: Mylan Bertek Pharmaceuticals
A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Mild to Moderate Hypertension
The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients with mild to moderate hypertension
Study Overview
Detailed Description
Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, laboratory assessments and genomics testing were performed before randomization.
Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy.
Patients had four scheduled clinical visits during the study, following the screening visit.
Study Type
Interventional
Enrollment
600
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:
- Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic.
Exclusion Criteria:
- Recent 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: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The change from baseline to week 12 in the average sitting DBP at trough.
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline to week 2, 6, and 12 in the average sitting, supine, standing systolic and diastolic blood pressure and sitting HR.
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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
October 1, 2002
Study Completion
October 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
- NEB321
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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