Heart Failure Clinical Trial

Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg

Summary

The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.

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Full Description

Study Further Study Details:

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Ability to read English
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:

Uncorrected obstructive or regurgitant valve disease
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.

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

400

Study ID:

NCT00272805

Recruitment Status:

Completed

Sponsor:

Cardiovascular Clinical Studies

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There are 54 Locations for this study

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The Heart Group
Mobile Alabama, 36608, United States
Radiant Research
Sierra Vista Arizona, 85635, United States
Cardiology Consultants of Orange County
Anaheim California, 92801, United States
Access Clinical Trials
Beverly Hills California, 90210, United States
Cardiovascular Consultants Medical Group
Oakland California, 94609, United States
San Diego Cardiac Center
San Diego California, 34203, United States
Northern California Medical Associates
Santa Rosa California, 95403, United States
Radiant Research
Santa Rosa California, 95405, United States
Cardiovascular Consultants Medical Group
Walnut Creek California, 94598, United States
Heart Center of the Rockies
Fort Collins Colorado, 80528, United States
St. Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
NextPhase Clinical Trials
Miami Florida, 33126, United States
Charlotte Heart Group Research Center
Port Charlotte Florida, 33952, United States
The Heart and Vascular Institute of Florida
St. Petersburg Florida, 33701, United States
Cardiac Disease Specialists
Atlanta Georgia, 30309, United States
CVMS Research Institute of Augusta
Augusta Georgia, 30901, United States
Georgia Heart Specialists
Covington Georgia, 30014, United States
Idaho Cardiology Associates
Boise Idaho, 83704, United States
North Shore Cardiologists
Bannockburn Illinois, 60015, United States
Midwest Heart Foundation
Lombard Illinois, 60148, United States
Illinois Heart and Lung Research Center
Normal Illinois, 61761, United States
The Care Group
Indianapolis Indiana, 46260, United States
Clinical Trials Management
Metairie Louisiana, 70006, United States
Androscoggin Cardiology Associates-Research
Auburn Maine, 04210, United States
Maine Cardiology Associates
S.Portland Maine, 04106, United States
Cardiovascular Consultants of Maine
Scarborough Maine, 04074, United States
Primary Care Cardiology Research
Ayer Massachusetts, 01432, United States
Lahey Clinic Cardiology
Burlington Massachusetts, 01805, United States
Pentucket Medical Associates
Haverhill Massachusetts, 01830, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Bryan LGH Heart Institute
Lincoln Nebraska, 68516, United States
Lovelace Scientific Resources
Las Vegas Nevada, 89128, United States
Associated Cardiovascular Consultants
Cherry Hill New Jersey, 08034, United States
University of New Mexico Health Science Center
Albuquerque New Mexico, 87131, United States
Albany Associates in Cardiology
Albany New York, 12205, United States
Cardiovascular Medical Associates
Garden City New York, 11530, United States
MidValley Cardiology
Kingston New York, 12401, United States
New York University Medical School
New York New York, 10016, United States
South Bay Cardiovascular Associates
West Islip New York, 11795, United States
Alamance Regional Medical Center
Burlington North Carolina, 27215, United States
Akron General Medical Center
Akron Ohio, 44307, United States
The Lindner Clinical Trial Center
Cincinnati Ohio, 45219, United States
New Horizons Clinical Research
Cincinnati Ohio, 45242, United States
The Dayton Heart Center
Dayton Ohio, 45414, United States
North Ohio Research Ltd.
Lorain Ohio, 44503, United States
North Ohio Research Ltd.
Sandusky Ohio, 44870, United States
Blue Stem Cardiology
Bartlesville Oklahoma, 74006, United States
Cardiovascular Consultants of Oregon
Corvallis Oregon, 97330, United States
Oregon Medical Group Clinical Research
Eugene Oregon, 97401, United States
Guthrie Clinic Ltd.
Sayre Pennsylvania, 18840, United States
Rhode Island Heart Failure Center
Providence Rhode Island, 02903, United States
DCOL Center for Clinical Research
Longview Texas, 75605, United States
LDS Hospital Cardiovascular Research
Salt Lake City Utah, 84143, United States
Arrythmia Center for Southern Wisconsin
Elkhorn Wisconsin, 53121, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

400

Study ID:

NCT00272805

Recruitment Status:

Completed

Sponsor:


Cardiovascular Clinical Studies

How clear is this clinincal trial information?

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