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

Last updated: February 15, 2013
Sponsor: Cardiovascular Clinical Studies
Overall Status: Completed

Phase

3

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT00272805
CCS 2005-001
CASPER
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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-betablockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.

Study Design

Total Participants: 400
Study Start date:
October 01, 2005
Estimated Completion Date:
July 31, 2006

Study 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.

Connect with a study center

  • The Heart Group

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Radiant Research

    Sierra Vista, Arizona 85635
    United States

    Site Not Available

  • Cardiology Consultants of Orange County

    Anaheim, California 92801
    United States

    Site Not Available

  • Access Clinical Trials

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Cardiovascular Consultants Medical Group

    Oakland, California 94609
    United States

    Site Not Available

  • San Diego Cardiac Center

    San Diego, California 34203
    United States

    Site Not Available

  • Northern California Medical Associates

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Radiant Research

    Santa Rosa, California 95405
    United States

    Site Not Available

  • Cardiovascular Consultants Medical Group

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Heart Center of the Rockies

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut 06105
    United States

    Site Not Available

  • NextPhase Clinical Trials

    Miami, Florida 33126
    United States

    Site Not Available

  • Charlotte Heart Group Research Center

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • The Heart and Vascular Institute of Florida

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Cardiac Disease Specialists

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • CVMS Research Institute of Augusta

    Augusta, Georgia 30901
    United States

    Site Not Available

  • Georgia Heart Specialists

    Covington, Georgia 30014
    United States

    Site Not Available

  • Idaho Cardiology Associates

    Boise, Idaho 83704
    United States

    Site Not Available

  • North Shore Cardiologists

    Bannockburn, Illinois 60015
    United States

    Site Not Available

  • Midwest Heart Foundation

    Lombard, Illinois 60148
    United States

    Site Not Available

  • Illinois Heart and Lung Research Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • The Care Group

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Clinical Trials Management

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Androscoggin Cardiology Associates-Research

    Auburn, Maine 04210
    United States

    Site Not Available

  • Maine Cardiology Associates

    S. Portland, Maine 04106
    United States

    Site Not Available

  • Maine Cardiology Associates

    S.Portland, Maine 04106
    United States

    Site Not Available

  • Cardiovascular Consultants of Maine

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Primary Care Cardiology Research

    Ayer, Massachusetts 01432
    United States

    Site Not Available

  • Lahey Clinic Cardiology

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Pentucket Medical Associates

    Haverhill, Massachusetts 01830
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Bryan LGH Heart Institute

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Lovelace Scientific Resources

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Associated Cardiovascular Consultants

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Albany Associates in Cardiology

    Albany, New York 12205
    United States

    Site Not Available

  • Cardiovascular Medical Associates

    Garden City, New York 11530
    United States

    Site Not Available

  • MidValley Cardiology

    Kingston, New York 12401
    United States

    Site Not Available

  • New York University Medical School

    New York, New York 10016
    United States

    Site Not Available

  • South Bay Cardiovascular Associates

    West Islip, New York 11795
    United States

    Site Not Available

  • Alamance Regional Medical Center

    Burlington, North Carolina 27215
    United States

    Site Not Available

  • Akron General Medical Center

    Akron, Ohio 44307
    United States

    Site Not Available

  • New Horizons Clinical Research

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Dayton Heart Center

    Dayton, Ohio 45414
    United States

    Site Not Available

  • North Ohio Research Ltd.

    Lorain, Ohio 44503
    United States

    Site Not Available

  • North Ohio Research Ltd.

    Sandusky, Ohio 44870
    United States

    Site Not Available

  • Blue Stem Cardiology

    Bartlesville, Oklahoma 74006
    United States

    Site Not Available

  • Cardiovascular Consultants of Oregon

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • Oregon Medical Group Clinical Research

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Guthrie Clinic Ltd.

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Rhode Island Heart Failure Center

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • DCOL Center for Clinical Research

    Longview, Texas 75605
    United States

    Site Not Available

  • LDS Hospital Cardiovascular Research

    Salt Lake City, Utah 84143
    United States

    Site Not Available

  • Arrythmia Center for Southern Wisconsin

    Elkhorn, Wisconsin 53121
    United States

    Site Not Available

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