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Chronic Heart FailurePhase 3NCT00272805

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

A Phase 3 study testing carvedilol in people with Chronic Heart Failure, run by Cardiovascular Clinical Sciences Inc at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
carvedilol
How many people
400 participants
Where
54 sitesUnited States
Study dates
Oct 2005to Jul 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Albany Associates in Cardiology

    Albany, New York, 12205

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico, 87131

  • Cardiology Consultants of Orange County

    Anaheim, California, 92801

  • Cardiac Disease Specialists

    Atlanta, Georgia, 30309

  • Androscoggin Cardiology Associates-Research

    Auburn, Maine, 04210

  • CVMS Research Institute of Augusta

    Augusta, Georgia, 30901

  • Primary Care Cardiology Research

    Ayer, Massachusetts, 01432

  • North Shore Cardiologists

    Bannockburn, Illinois, 60015

  • Blue Stem Cardiology

    Bartlesville, Oklahoma, 74006

  • Access Clinical Trials

    Beverly Hills, California, 90210

  • Idaho Cardiology Associates

    Boise, Idaho, 83704

  • Lahey Clinic Cardiology

    Burlington, Massachusetts, 01805

  • Alamance Regional Medical Center

    Burlington, North Carolina, 27215

  • Associated Cardiovascular Consultants

    Cherry Hill, New Jersey, 08034

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Cardiovascular Consultants of Oregon

    Corvallis, Oregon, 97330

  • Georgia Heart Specialists

    Covington, Georgia, 30014

  • The Dayton Heart Center

    Dayton, Ohio, 45414

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Arrythmia Center for Southern Wisconsin

    Elkhorn, Wisconsin, 53121

  • Oregon Medical Group Clinical Research

    Eugene, Oregon, 97401

  • Heart Center of the Rockies

    Fort Collins, Colorado, 80528

  • Cardiovascular Medical Associates

    Garden City, New York, 11530

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Pentucket Medical Associates

    Haverhill, Massachusetts, 01830

  • The Care Group

    Indianapolis, Indiana, 46260

  • MidValley Cardiology

    Kingston, New York, 12401

  • Lovelace Scientific Resources

    Las Vegas, Nevada, 89128

  • Bryan LGH Heart Institute

    Lincoln, Nebraska, 68516

  • Midwest Heart Foundation

    Lombard, Illinois, 60148

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • North Ohio Research Ltd.

    Lorain, Ohio, 44503

  • Clinical Trials Management

    Metairie, Louisiana, 70006

  • NextPhase Clinical Trials

    Miami, Florida, 33126

  • The Heart Group

    Mobile, Alabama, 36608

  • New York University Medical School

    New York, New York, 10016

  • Illinois Heart and Lung Research Center

    Normal, Illinois, 61761

  • Cardiovascular Consultants Medical Group

    Oakland, California, 94609

  • Charlotte Heart Group Research Center

    Port Charlotte, Florida, 33952

  • Rhode Island Heart Failure Center

    Providence, Rhode Island, 02903

  • Maine Cardiology Associates

    S.Portland, Maine, 04106

  • LDS Hospital Cardiovascular Research

    Salt Lake City, Utah, 84143

  • San Diego Cardiac Center

    San Diego, California, 34203

  • North Ohio Research Ltd.

    Sandusky, Ohio, 44870

  • Northern California Medical Associates

    Santa Rosa, California, 95403

  • Radiant Research

    Santa Rosa, California, 95405

  • Guthrie Clinic Ltd.

    Sayre, Pennsylvania, 18840

  • Cardiovascular Consultants of Maine

    Scarborough, Maine, 04074

  • Radiant Research

    Sierra Vista, Arizona, 85635

  • The Heart and Vascular Institute of Florida

    St. Petersburg, Florida, 33701

  • Cardiovascular Consultants Medical Group

    Walnut Creek, California, 94598

  • South Bay Cardiovascular Associates

    West Islip, New York, 11795

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
carvedilol
Keywords
chronic heart failure, left ventricular systolic dysfunction
Medical subject headings
Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carvedilolDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dosing compliance: pill taking total taken vs number prescribed

Secondary outcomes (1)

  1. quality of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
400 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00272805
Sponsor's protocol ID
CCS 2005-001
Other IDs
CASPER
Status last verified
Feb 2013
First submitted
5 Jan 2006
Last updated
18 Feb 2013
Results posted
No

Publications

  • 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.

    PubMed 19477398

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carvedilol in people with Chronic Heart Failure, run by Cardiovascular Clinical Sciences Inc at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dosing compliance: pill taking total taken vs number prescribed. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00272805, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.

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