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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
carvedilol
Sponsored by
Cardiovascular Clinical Studies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, left ventricular systolic dysfunction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Heart Group
  • Radiant Research
  • Cardiology Consultants of Orange County
  • Access Clinical Trials
  • Cardiovascular Consultants Medical Group
  • San Diego Cardiac Center
  • Northern California Medical Associates
  • Radiant Research
  • Cardiovascular Consultants Medical Group
  • Heart Center of the Rockies
  • St. Francis Hospital and Medical Center
  • NextPhase Clinical Trials
  • Charlotte Heart Group Research Center
  • The Heart and Vascular Institute of Florida
  • Cardiac Disease Specialists
  • CVMS Research Institute of Augusta
  • Georgia Heart Specialists
  • Idaho Cardiology Associates
  • North Shore Cardiologists
  • Midwest Heart Foundation
  • Illinois Heart and Lung Research Center
  • The Care Group
  • Clinical Trials Management
  • Androscoggin Cardiology Associates-Research
  • Maine Cardiology Associates
  • Cardiovascular Consultants of Maine
  • Primary Care Cardiology Research
  • Lahey Clinic Cardiology
  • Pentucket Medical Associates
  • Henry Ford Hospital
  • Bryan LGH Heart Institute
  • Lovelace Scientific Resources
  • Associated Cardiovascular Consultants
  • University of New Mexico Health Science Center
  • Albany Associates in Cardiology
  • Cardiovascular Medical Associates
  • MidValley Cardiology
  • New York University Medical School
  • South Bay Cardiovascular Associates
  • Alamance Regional Medical Center
  • Akron General Medical Center
  • The Lindner Clinical Trial Center
  • New Horizons Clinical Research
  • The Dayton Heart Center
  • North Ohio Research Ltd.
  • North Ohio Research Ltd.
  • Blue Stem Cardiology
  • Cardiovascular Consultants of Oregon
  • Oregon Medical Group Clinical Research
  • Guthrie Clinic Ltd.
  • Rhode Island Heart Failure Center
  • DCOL Center for Clinical Research
  • LDS Hospital Cardiovascular Research
  • Arrythmia Center for Southern Wisconsin

Outcomes

Primary Outcome Measures

Dosing compliance: pill taking total taken vs number prescribed

Secondary Outcome Measures

quality of life

Full Information

First Posted
January 5, 2006
Last Updated
February 15, 2013
Sponsor
Cardiovascular Clinical Studies
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00272805
Brief Title
Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiovascular Clinical Studies
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, left ventricular systolic dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carvedilol
Primary Outcome Measure Information:
Title
Dosing compliance: pill taking total taken vs number prescribed
Secondary Outcome Measure Information:
Title
quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E. Udelson, M.D.
Organizational Affiliation
Cardiovascular Clinical Studies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Heart Group
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Radiant Research
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
Facility Name
Cardiology Consultants of Orange County
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Access Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Cardiovascular Consultants Medical Group
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
San Diego Cardiac Center
City
San Diego
State/Province
California
ZIP/Postal Code
34203
Country
United States
Facility Name
Northern California Medical Associates
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Cardiovascular Consultants Medical Group
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Heart Center of the Rockies
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
St. Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
NextPhase Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Charlotte Heart Group Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
The Heart and Vascular Institute of Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Cardiac Disease Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
CVMS Research Institute of Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Georgia Heart Specialists
City
Covington
State/Province
Georgia
ZIP/Postal Code
30014
Country
United States
Facility Name
Idaho Cardiology Associates
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
North Shore Cardiologists
City
Bannockburn
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Illinois Heart and Lung Research Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
The Care Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Androscoggin Cardiology Associates-Research
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Maine Cardiology Associates
City
S.Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
Cardiovascular Consultants of Maine
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Primary Care Cardiology Research
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Facility Name
Lahey Clinic Cardiology
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Pentucket Medical Associates
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Bryan LGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Lovelace Scientific Resources
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Associated Cardiovascular Consultants
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
University of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albany Associates in Cardiology
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Cardiovascular Medical Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
MidValley Cardiology
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
New York University Medical School
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
South Bay Cardiovascular Associates
City
West Islip
State/Province
New York
ZIP/Postal Code
11795
Country
United States
Facility Name
Alamance Regional Medical Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Dayton Heart Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
North Ohio Research Ltd.
City
Lorain
State/Province
Ohio
ZIP/Postal Code
44503
Country
United States
Facility Name
North Ohio Research Ltd.
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Blue Stem Cardiology
City
Bartlesville
State/Province
Oklahoma
ZIP/Postal Code
74006
Country
United States
Facility Name
Cardiovascular Consultants of Oregon
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Oregon Medical Group Clinical Research
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Guthrie Clinic Ltd.
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Rhode Island Heart Failure Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
LDS Hospital Cardiovascular Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Arrythmia Center for Southern Wisconsin
City
Elkhorn
State/Province
Wisconsin
ZIP/Postal Code
53121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19477398
Citation
Udelson JE, Pressler SJ, Sackner-Bernstein J, Massaro J, Ordronneau P, Lukas MA, Hauptman PJ. Adherence with once daily versus twice daily carvedilol in patients with heart failure: the Compliance And Quality of Life Study Comparing Once-Daily Controlled-Release Carvedilol CR and Twice-Daily Immediate-Release Carvedilol IR in Patients with Heart Failure (CASPER) Trial. J Card Fail. 2009 Jun;15(5):385-93. doi: 10.1016/j.cardfail.2008.12.010. Epub 2009 Feb 12.
Results Reference
derived

Learn more about this trial

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

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