NCT00272805

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: Cardiovascular Clinical Sciences Inc · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	carvedilol

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2006-01-09
• Last updated: 2013-02-18

Locations

54 sites across 1 country: United States