Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg
NCT ID: NCT00272805
Last Updated: 2013-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2005-10-31
2006-07-31
Brief Summary
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Detailed Description
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Primary outcome: pill-taking compliance (total doses taken versus total doses prescribed)
Expected Total Enrollment: 400 subjects at 56 study sites in the U.S.
Study Start: October 2005
This is a 5-month double-blind treatment study of male and female subjects with stable mild-to-severe chronic heart failure and with left ventricular dysfunction with symptoms of heart failure.
Eligibility:
Must be stable on treatment with Coreg IR at a standard dose: 6.25, 12.5, 25 mg twice a day.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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carvedilol
Eligibility Criteria
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Inclusion Criteria
* Stable symptoms of mild to severe heart failure
* Stable medical regimen for heart failure
* On a stable dose of Coreg for at least 2 months
* LVEF ≤40% within the previous 24 months
Exclusion Criteria
* Complex congenital heart disease
* Recent ICD or pacemaker placement
* Recent coronary artery bypass surgery or stroke
* Candidate for heart transplanct within 5 months of study start
* Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.
18 Years
90 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Cardiovascular Clinical Sciences Inc
INDUSTRY
Responsible Party
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Principal Investigators
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James E. Udelson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Clinical Studies, Inc.
Locations
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The Heart Group
Mobile, Alabama, United States
Radiant Research
Sierra Vista, Arizona, United States
Cardiology Consultants of Orange County
Anaheim, California, United States
Access Clinical Trials
Beverly Hills, California, United States
Cardiovascular Consultants Medical Group
Oakland, California, United States
San Diego Cardiac Center
San Diego, California, United States
Northern California Medical Associates
Santa Rosa, California, United States
Radiant Research
Santa Rosa, California, United States
Cardiovascular Consultants Medical Group
Walnut Creek, California, United States
Heart Center of the Rockies
Fort Collins, Colorado, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
NextPhase Clinical Trials
Miami, Florida, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, United States
Cardiac Disease Specialists
Atlanta, Georgia, United States
CVMS Research Institute of Augusta
Augusta, Georgia, United States
Georgia Heart Specialists
Covington, Georgia, United States
Idaho Cardiology Associates
Boise, Idaho, United States
North Shore Cardiologists
Bannockburn, Illinois, United States
Midwest Heart Foundation
Lombard, Illinois, United States
Illinois Heart and Lung Research Center
Normal, Illinois, United States
The Care Group
Indianapolis, Indiana, United States
Clinical Trials Management
Metairie, Louisiana, United States
Androscoggin Cardiology Associates-Research
Auburn, Maine, United States
Maine Cardiology Associates
S.Portland, Maine, United States
Cardiovascular Consultants of Maine
Scarborough, Maine, United States
Primary Care Cardiology Research
Ayer, Massachusetts, United States
Lahey Clinic Cardiology
Burlington, Massachusetts, United States
Pentucket Medical Associates
Haverhill, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, United States
Lovelace Scientific Resources
Las Vegas, Nevada, United States
Associated Cardiovascular Consultants
Cherry Hill, New Jersey, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
Albany Associates in Cardiology
Albany, New York, United States
Cardiovascular Medical Associates
Garden City, New York, United States
MidValley Cardiology
Kingston, New York, United States
New York University Medical School
New York, New York, United States
South Bay Cardiovascular Associates
West Islip, New York, United States
Alamance Regional Medical Center
Burlington, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
The Dayton Heart Center
Dayton, Ohio, United States
North Ohio Research Ltd.
Lorain, Ohio, United States
North Ohio Research Ltd.
Sandusky, Ohio, United States
Blue Stem Cardiology
Bartlesville, Oklahoma, United States
Cardiovascular Consultants of Oregon
Corvallis, Oregon, United States
Oregon Medical Group Clinical Research
Eugene, Oregon, United States
Guthrie Clinic Ltd.
Sayre, Pennsylvania, United States
Rhode Island Heart Failure Center
Providence, Rhode Island, United States
DCOL Center for Clinical Research
Longview, Texas, United States
LDS Hospital Cardiovascular Research
Salt Lake City, Utah, United States
Arrythmia Center for Southern Wisconsin
Elkhorn, Wisconsin, United States
Countries
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References
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Udelson JE, Pressler SJ, Sackner-Bernstein J, Massaro J, Ordronneau P, Lukas MA, Hauptman PJ. Adherence with once daily versus twice daily carvedilol in patients with heart failure: the Compliance And Quality of Life Study Comparing Once-Daily Controlled-Release Carvedilol CR and Twice-Daily Immediate-Release Carvedilol IR in Patients with Heart Failure (CASPER) Trial. J Card Fail. 2009 Jun;15(5):385-93. doi: 10.1016/j.cardfail.2008.12.010. Epub 2009 Feb 12.
Other Identifiers
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CASPER
Identifier Type: -
Identifier Source: secondary_id
CCS 2005-001
Identifier Type: -
Identifier Source: org_study_id
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