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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.
Study NCT00272805   Information provided by Cardiovascular Clinical Studies
First Received: January 5, 2006   Last Updated: February 6, 2006   History of Changes

January 5, 2006
February 6, 2006
October 2005
 
Dosing compliance: pill taking total taken vs number prescribed
Same as current
Complete list of historical versions of study NCT00272805 on ClinicalTrials.gov Archive Site
quality of life
Same as current
 
Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-Daily or Twice-Daily Coreg
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 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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Chronic Heart Failure
Drug: carvedilol
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
400
 
 

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00272805
 
CCS 2005-001, CASPER
Cardiovascular Clinical Studies
GlaxoSmithKline
Principal Investigator: James E. Udelson, M.D. Cardiovascular Clinical Studies, Inc.
Cardiovascular Clinical Studies
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP