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

This study is ongoing, but not recruiting participants.

First Received: January 5, 2006 Last Updated: February 6, 2006 History of Changes

Sponsors and Collaborators:	Cardiovascular Clinical Studies GlaxoSmithKline
Information provided by:	Cardiovascular Clinical Studies
ClinicalTrials.gov Identifier:	NCT00272805

Purpose

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.

Condition	Intervention	Phase
Chronic Heart Failure	Drug: carvedilol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Carvedilol

U.S. FDA Resources

Further study details as provided by Cardiovascular Clinical Studies:

Primary Outcome Measures:

Dosing compliance: pill taking total taken vs number prescribed

Secondary Outcome Measures:

quality of life

Estimated Enrollment:	400
Study Start Date:	October 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272805

Show 54 Study Locations

Sponsors and Collaborators

Cardiovascular Clinical Studies

GlaxoSmithKline

Investigators

Principal Investigator:

James E. Udelson, M.D.

Cardiovascular Clinical Studies, Inc.

More Information

No publications provided by Cardiovascular Clinical Studies

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2009 Feb 12.

Study ID Numbers:	CCS 2005-001, CASPER
Study First Received:	January 5, 2006
Last Updated:	February 6, 2006
ClinicalTrials.gov Identifier:	NCT00272805 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cardiovascular Clinical Studies:

chronic heart failure
left ventricular systolic dysfunction

Study placed in the following topic categories:

Vasodilator Agents
Neurotransmitter Agents
Heart Failure
Heart Diseases
Adrenergic Agents
Adrenergic beta-Antagonists

Quality of Life
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Carvedilol

Additional relevant MeSH terms:

Vasodilator Agents
Heart Failure
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Carvedilol

ClinicalTrials.gov processed this record on September 01, 2009