Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg
Sponsor
Cardiovascular Clinical Studies (Other)
Overall Status
Completed
CT.gov ID
NCT00272805
Collaborator
GlaxoSmithKline (Industry)
400
54
9
7.4
0.8
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Oct 1, 2005
Actual Primary Completion Date
:
Jul 1, 2006
Actual Study Completion Date
:
Jul 1, 2006
Outcome Measures
Primary Outcome Measures
- Dosing compliance: pill taking total taken vs number prescribed []
Secondary Outcome Measures
- quality of life []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Heart Group | Mobile | Alabama | United States | 36608 |
| 2 | Radiant Research | Sierra Vista | Arizona | United States | 85635 |
| 3 | Cardiology Consultants of Orange County | Anaheim | California | United States | 92801 |
| 4 | Access Clinical Trials | Beverly Hills | California | United States | 90210 |
| 5 | Cardiovascular Consultants Medical Group | Oakland | California | United States | 94609 |
| 6 | San Diego Cardiac Center | San Diego | California | United States | 34203 |
| 7 | Northern California Medical Associates | Santa Rosa | California | United States | 95403 |
| 8 | Radiant Research | Santa Rosa | California | United States | 95405 |
| 9 | Cardiovascular Consultants Medical Group | Walnut Creek | California | United States | 94598 |
| 10 | Heart Center of the Rockies | Fort Collins | Colorado | United States | 80528 |
| 11 | St. Francis Hospital and Medical Center | Hartford | Connecticut | United States | 06105 |
| 12 | NextPhase Clinical Trials | Miami | Florida | United States | 33126 |
| 13 | Charlotte Heart Group Research Center | Port Charlotte | Florida | United States | 33952 |
| 14 | The Heart and Vascular Institute of Florida | St. Petersburg | Florida | United States | 33701 |
| 15 | Cardiac Disease Specialists | Atlanta | Georgia | United States | 30309 |
| 16 | CVMS Research Institute of Augusta | Augusta | Georgia | United States | 30901 |
| 17 | Georgia Heart Specialists | Covington | Georgia | United States | 30014 |
| 18 | Idaho Cardiology Associates | Boise | Idaho | United States | 83704 |
| 19 | North Shore Cardiologists | Bannockburn | Illinois | United States | 60015 |
| 20 | Midwest Heart Foundation | Lombard | Illinois | United States | 60148 |
| 21 | Illinois Heart and Lung Research Center | Normal | Illinois | United States | 61761 |
| 22 | The Care Group | Indianapolis | Indiana | United States | 46260 |
| 23 | Clinical Trials Management | Metairie | Louisiana | United States | 70006 |
| 24 | Androscoggin Cardiology Associates-Research | Auburn | Maine | United States | 04210 |
| 25 | Maine Cardiology Associates | S.Portland | Maine | United States | 04106 |
| 26 | Cardiovascular Consultants of Maine | Scarborough | Maine | United States | 04074 |
| 27 | Primary Care Cardiology Research | Ayer | Massachusetts | United States | 01432 |
| 28 | Lahey Clinic Cardiology | Burlington | Massachusetts | United States | 01805 |
| 29 | Pentucket Medical Associates | Haverhill | Massachusetts | United States | 01830 |
| 30 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 31 | Bryan LGH Heart Institute | Lincoln | Nebraska | United States | 68516 |
| 32 | Lovelace Scientific Resources | Las Vegas | Nevada | United States | 89128 |
| 33 | Associated Cardiovascular Consultants | Cherry Hill | New Jersey | United States | 08034 |
| 34 | University of New Mexico Health Science Center | Albuquerque | New Mexico | United States | 87131 |
| 35 | Albany Associates in Cardiology | Albany | New York | United States | 12205 |
| 36 | Cardiovascular Medical Associates | Garden City | New York | United States | 11530 |
| 37 | MidValley Cardiology | Kingston | New York | United States | 12401 |
| 38 | New York University Medical School | New York | New York | United States | 10016 |
| 39 | South Bay Cardiovascular Associates | West Islip | New York | United States | 11795 |
| 40 | Alamance Regional Medical Center | Burlington | North Carolina | United States | 27215 |
| 41 | Akron General Medical Center | Akron | Ohio | United States | 44307 |
| 42 | The Lindner Clinical Trial Center | Cincinnati | Ohio | United States | 45219 |
| 43 | New Horizons Clinical Research | Cincinnati | Ohio | United States | 45242 |
| 44 | The Dayton Heart Center | Dayton | Ohio | United States | 45414 |
| 45 | North Ohio Research Ltd. | Lorain | Ohio | United States | 44503 |
| 46 | North Ohio Research Ltd. | Sandusky | Ohio | United States | 44870 |
| 47 | Blue Stem Cardiology | Bartlesville | Oklahoma | United States | 74006 |
| 48 | Cardiovascular Consultants of Oregon | Corvallis | Oregon | United States | 97330 |
| 49 | Oregon Medical Group Clinical Research | Eugene | Oregon | United States | 97401 |
| 50 | Guthrie Clinic Ltd. | Sayre | Pennsylvania | United States | 18840 |
| 51 | Rhode Island Heart Failure Center | Providence | Rhode Island | United States | 02903 |
| 52 | DCOL Center for Clinical Research | Longview | Texas | United States | 75605 |
| 53 | LDS Hospital Cardiovascular Research | Salt Lake City | Utah | United States | 84143 |
| 54 | Arrythmia Center for Southern Wisconsin | Elkhorn | Wisconsin | United States | 53121 |
Sponsors and Collaborators
- Cardiovascular Clinical Studies
- GlaxoSmithKline
Investigators
- Principal Investigator: James E. Udelson, M.D., Cardiovascular Clinical Studies, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cardiovascular Clinical Studies
ClinicalTrials.gov Identifier:
NCT00272805
Other Study ID Numbers:
- CCS 2005-001
- CASPER
First Posted:
Jan 9, 2006
Last Update Posted:
Feb 18, 2013
Last Verified:
Feb 1, 2013
Keywords provided by Cardiovascular Clinical Studies
Additional relevant MeSH terms: