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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00272805

Enrollment

400

Registered

2006-01-09

Start date

2005-10-31

Completion date

2006-07-31

Last updated

2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

chronic heart failure, left ventricular systolic dysfunction

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.

Interventions

DRUGcarvedilol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame
Dosing compliance: pill taking total taken vs number prescribed	—

Secondary

Measure	Time frame
quality of life	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026