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| Sponsor: | Cardiovascular Clinical Studies |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Cardiovascular Clinical Studies |
| ClinicalTrials.gov Identifier: | NCT00272805 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Heart Failure |
Drug: carvedilol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment |
| 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 |
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| The Heart Group | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Radiant Research | |
| Sierra Vista, Arizona, United States, 85635 | |
| United States, California | |
| Northern California Medical Associates | |
| Santa Rosa, California, United States, 95403 | |
| San Diego Cardiac Center | |
| San Diego, California, United States, 34203 | |
| Radiant Research | |
| Santa Rosa, California, United States, 95405 | |
| Cardiology Consultants of Orange County | |
| Anaheim, California, United States, 92801 | |
| Access Clinical Trials | |
| Beverly Hills, California, United States, 90210 | |
| Cardiovascular Consultants Medical Group | |
| Walnut Creek, California, United States, 94598 | |
| Cardiovascular Consultants Medical Group | |
| Oakland, California, United States, 94609 | |
| United States, Colorado | |
| Heart Center of the Rockies | |
| Fort Collins, Colorado, United States, 80528 | |
| United States, Connecticut | |
| St. Francis Hospital and Medical Center | |
| Hartford, Connecticut, United States, 06105 | |
| United States, Florida | |
| NextPhase Clinical Trials | |
| Miami, Florida, United States, 33126 | |
| Charlotte Heart Group Research Center | |
| Port Charlotte, Florida, United States, 33952 | |
| The Heart and Vascular Institute of Florida | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Georgia | |
| CVMS Research Institute of Augusta | |
| Augusta, Georgia, United States, 30901 | |
| Georgia Heart Specialists | |
| Covington, Georgia, United States, 30014 | |
| Cardiac Disease Specialists | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Idaho | |
| Idaho Cardiology Associates | |
| Boise, Idaho, United States, 83704 | |
| United States, Illinois | |
| North Shore Cardiologists | |
| Bannockburn, Illinois, United States, 60015 | |
| Illinois Heart and Lung Research Center | |
| Normal, Illinois, United States, 61761 | |
| Midwest Heart Foundation | |
| Lombard, Illinois, United States, 60148 | |
| United States, Indiana | |
| The Care Group | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Louisiana | |
| Clinical Trials Management | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maine | |
| Cardiovascular Consultants of Maine | |
| Scarborough, Maine, United States, 04074 | |
| Androscoggin Cardiology Associates-Research | |
| Auburn, Maine, United States, 04210 | |
| Maine Cardiology Associates | |
| S. Portland, Maine, United States, 04106 | |
| United States, Massachusetts | |
| Pentucket Medical Associates | |
| Haverhill, Massachusetts, United States, 01830 | |
| Primary Care Cardiology Research | |
| Ayer, Massachusetts, United States, 01432 | |
| Lahey Clinic Cardiology | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Nebraska | |
| Bryan LGH Heart Institute | |
| Lincoln, Nebraska, United States, 68516 | |
| United States, Nevada | |
| Lovelace Scientific Resources | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Jersey | |
| Associated Cardiovascular Consultants | |
| Cherry Hill, New Jersey, United States, 08034 | |
| United States, New Mexico | |
| University of New Mexico Health Science Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| South Bay Cardiovascular Associates | |
| West Islip, New York, United States, 11795 | |
| Cardiovascular Medical Associates | |
| Garden City, New York, United States, 11530 | |
| New York University Medical School | |
| New York, New York, United States, 10016 | |
| MidValley Cardiology | |
| Kingston, New York, United States, 12401 | |
| Albany Associates in Cardiology | |
| Albany, New York, United States, 12205 | |
| United States, North Carolina | |
| Alamance Regional Medical Center | |
| Burlington, North Carolina, United States, 27215 | |
| United States, Ohio | |
| The Lindner Clinical Trial Center | |
| Cincinnati, Ohio, United States, 45219 | |
| The Dayton Heart Center | |
| Dayton, Ohio, United States, 45414 | |
| New Horizons Clinical Research | |
| Cincinnati, Ohio, United States, 45242 | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| North Ohio Research Ltd. | |
| Sandusky, Ohio, United States, 44870 | |
| North Ohio Research Ltd. | |
| Lorain, Ohio, United States, 44503 | |
| United States, Oklahoma | |
| Blue Stem Cardiology | |
| Bartlesville, Oklahoma, United States, 74006 | |
| United States, Oregon | |
| Cardiovascular Consultants of Oregon | |
| Corvallis, Oregon, United States, 97330 | |
| Oregon Medical Group Clinical Research | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Guthrie Clinic Ltd. | |
| Sayre, Pennsylvania, United States, 18840 | |
| United States, Rhode Island | |
| Rhode Island Heart Failure Center | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Texas | |
| DCOL Center for Clinical Research | |
| Longview, Texas, United States, 75605 | |
| United States, Utah | |
| LDS Hospital Cardiovascular Research | |
| Salt Lake City, Utah, United States, 84143 | |
| United States, Wisconsin | |
| Arrythmia Center for Southern Wisconsin | |
| Elkhorn, Wisconsin, United States, 53121 | |
| Principal Investigator: | James E. Udelson, M.D. | Cardiovascular Clinical Studies, Inc. |
More Information
| Study ID Numbers: | CCS 2005-001, CASPER |
| Study First Received: | January 5, 2006 |
| Last Updated: | February 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00272805 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
chronic heart failure left ventricular systolic dysfunction |
|
Vasodilator Agents Heart Failure Neurotransmitter Agents Heart Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Carvedilol |
