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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272805
• Other study ID #: CCS 2005-001
• Secondary ID: CASPER
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2006
• Last updated: February 15, 2013
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: February 2013
• Source: Cardiovascular Clinical Studies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Ventricular Dysfunction, Left

Intervention

Drug:
• carvedilol

Locations

Country	Name	City	State
United States	Akron General Medical Center	Akron	Ohio
United States	Albany Associates in Cardiology	Albany	New York
United States	University of New Mexico Health Science Center	Albuquerque	New Mexico
United States	Cardiology Consultants of Orange County	Anaheim	California
United States	Cardiac Disease Specialists	Atlanta	Georgia
United States	Androscoggin Cardiology Associates-Research	Auburn	Maine
United States	CVMS Research Institute of Augusta	Augusta	Georgia
United States	Primary Care Cardiology Research	Ayer	Massachusetts
United States	North Shore Cardiologists	Bannockburn	Illinois
United States	Blue Stem Cardiology	Bartlesville	Oklahoma
United States	Access Clinical Trials	Beverly Hills	California
United States	Idaho Cardiology Associates	Boise	Idaho
United States	Alamance Regional Medical Center	Burlington	North Carolina
United States	Lahey Clinic Cardiology	Burlington	Massachusetts
United States	Associated Cardiovascular Consultants	Cherry Hill	New Jersey
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Cardiovascular Consultants of Oregon	Corvallis	Oregon
United States	Georgia Heart Specialists	Covington	Georgia
United States	The Dayton Heart Center	Dayton	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Arrythmia Center for Southern Wisconsin	Elkhorn	Wisconsin
United States	Oregon Medical Group Clinical Research	Eugene	Oregon
United States	Heart Center of the Rockies	Fort Collins	Colorado
United States	Cardiovascular Medical Associates	Garden City	New York
United States	St. Francis Hospital and Medical Center	Hartford	Connecticut
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	The Care Group	Indianapolis	Indiana
United States	MidValley Cardiology	Kingston	New York
United States	Lovelace Scientific Resources	Las Vegas	Nevada
United States	Bryan LGH Heart Institute	Lincoln	Nebraska
United States	Midwest Heart Foundation	Lombard	Illinois
United States	DCOL Center for Clinical Research	Longview	Texas
United States	North Ohio Research Ltd.	Lorain	Ohio
United States	Clinical Trials Management	Metairie	Louisiana
United States	NextPhase Clinical Trials	Miami	Florida
United States	The Heart Group	Mobile	Alabama
United States	New York University Medical School	New York	New York
United States	Illinois Heart and Lung Research Center	Normal	Illinois
United States	Cardiovascular Consultants Medical Group	Oakland	California
United States	Charlotte Heart Group Research Center	Port Charlotte	Florida
United States	Rhode Island Heart Failure Center	Providence	Rhode Island
United States	Maine Cardiology Associates	S.Portland	Maine
United States	LDS Hospital Cardiovascular Research	Salt Lake City	Utah
United States	San Diego Cardiac Center	San Diego	California
United States	North Ohio Research Ltd.	Sandusky	Ohio
United States	Northern California Medical Associates	Santa Rosa	California
United States	Radiant Research	Santa Rosa	California
United States	Guthrie Clinic Ltd.	Sayre	Pennsylvania
United States	Cardiovascular Consultants of Maine	Scarborough	Maine
United States	Radiant Research	Sierra Vista	Arizona
United States	The Heart and Vascular Institute of Florida	St. Petersburg	Florida
United States	Cardiovascular Consultants Medical Group	Walnut Creek	California
United States	South Bay Cardiovascular Associates	West Islip	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cardiovascular Clinical Studies	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosing compliance: pill taking total taken vs number prescribed
Secondary	quality of life