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

Cardiovascular Clinical Studies

Status and phase

Completed

Phase 3

Conditions

Chronic Heart Failure

Treatments

Drug: carvedilol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00272805

CASPER

CCS 2005-001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.