The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease
Information source: Forest Laboratories
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Coronary Artery Disease
Intervention: Nebivolol (Drug); Carvedilol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Forest Laboratories Official(s) and/or principal investigator(s):
David Bharucha, MD, PhD, Study Director, Affiliation: Forest Laboratories
Overall contact:
Sandra Beaird, PharmD, Phone: 800-678-1605, Ext: 66297, Email: info@forestpharm.com
Summary
This study is being done to see if the blood pressure lowering effect of an approved drug
nebivolol is comparable to that of another approved drug carvedilol for the treatment of
hypertension in patients who have coronary artery disease.
Clinical Details
Official title: Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Peripheral diastolic blood pressure (DBP)
Secondary outcome: Peripheral systolic blood pressure (SBP)
Detailed description:
This study is double blind (neither the patient nor the physician will know which drug is
being administered). Each drug has been approved by the FDA for the treatment of
hypertension. The study is being conducted in about 160 patients at approximately 30
research centers in the United States.
The study consists of approximately 18 study visits over a period of 6 months.
During these visits, patients will undergo routine health exams. In addition, exercise test
and echocardiogram (an ultrasound of the heart) results will be collected. Information on
symptoms, side effects, and how the study drugs are tolerated will also be collected.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female ambulatory outpatients 18 to 85 of age at screening
- Coronary artery disease with recent (within 14 to 180 days) heart attack with follow
up stress testing
- Qualifying blood pressure criteria for study entry and for randomization
- Willing to adhere to exercise stress (treadmill) tests
Exclusion Criteria:
- Unstable angina within 7 days of screening
- Potential coronary surgical/intervention within the next 6 months
- Have any form of secondary hypertension
- Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta
blocker
Locations and Contacts
Sandra Beaird, PharmD, Phone: 800-678-1605, Ext: 66297, Email: info@forestpharm.com
Forest Investigative Site, Birmingham, Alabama 35294, United States; Recruiting
Forest Investigative Site, Peoria, Arizona 85381, United States; Recruiting
Forest Investigative Site, Los Angeles, California 90048, United States; Recruiting
Forest Investigative Site, Orange, California 92868, United States; Recruiting
Forest Investigative Site, Buena Park, California 90620, United States; Not yet recruiting
Forest Investigative Site, Guilford, Connecticut 06437, United States; Recruiting
Forest Investigative Site, Lauderdale Lakes, Florida 33313, United States; Recruiting
Forest Investigative Site, Orlando, Florida 32803, United States; Recruiting
Forest Investigative Site, Daytona Beach, Florida 32117, United States; Recruiting
Forest Investigative Site, Chicago, Illinois 60611, United States; Not yet recruiting
Forest Investigative Site, Pittsfield, Massachusetts 01201, United States; Recruiting
Forest Investigative Site, Lansing, Michigan 48910, United States; Recruiting
Forest Investigative Site, Detroit, Michigan 48202, United States; Recruiting
Forest Investigative Site, Northport, New York 11768, United States; Recruiting
Forest Investigative Site, Bronx, New York 10468, United States; Recruiting
Forest Investigative Site, New York, New York 10029, United States; Not yet recruiting
Forest Investigative Site, Bronx, New York 10451, United States; Not yet recruiting
Forest Investigative Site, Charlotte, North Carolina 28211, United States; Recruiting
Forest Investigative Site, Fargo, North Dakota 58103, United States; Recruiting
Forest Investigative Site, Cincinnati, Ohio 45219, United States; Recruiting
Forest Investigative Site, Lancaster, Pennsylvania 17603, United States; Recruiting
Forest Investigative Site, Charleston, South Carolina 29401, United States; Not yet recruiting
Forest Investigative Site, Cleveland, Tennessee 37312, United States; Recruiting
Forest Investigative Site, Carrollton, Texas 75006, United States; Recruiting
Additional Information
Starting date: May 2008
Last updated: January 12, 2009
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