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

Cardiovascular Clinical Studies51 sites in 1 country400 target enrollmentOctober 2005

ConditionsChronic Heart Failure

Drugscarvedilol

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Heart Failure
Sponsor: Cardiovascular Clinical Studies
Enrollment: 400
Locations: 51
Primary Endpoint: Dosing compliance: pill taking total taken vs number prescribed
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

July 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cardiovascular Clinical Studies

Responsible Party

Sponsor

Eligibility 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.