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

February 15, 2013 updated by: Cardiovascular Clinical Studies

Prospective, Randomized, Controlled Assessment of Once-Daily Controlled Release COREG CR vs Twice-Daily COREG Immediate Release(IR)on Measures of Compliance and Quality of Life in Patients With Heart Failure and Left Ventricular Systolic Dysfunction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

400

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

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

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
Dosing compliance: pill taking total taken vs number prescribed

Secondary Outcome Measures

Outcome Measure
quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular Clinical Studies

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: James E. Udelson, M.D., Cardiovascular Clinical Studies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

January 5, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCS 2005-001
  • CASPeR

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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