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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 5, 2006 | ||||
| Last Updated Date | February 6, 2006 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Dosing compliance: pill taking total taken vs number prescribed | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00272805 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
quality of life | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-Daily or Twice-Daily Coreg | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment | ||||
| Condition ICMJE | Chronic Heart Failure | ||||
| Intervention ICMJE | Drug: carvedilol | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. Epub 2009 Feb 12. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00272805 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CCS 2005-001, CASPER | ||||
| Study Sponsor ICMJE | Cardiovascular Clinical Studies | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | Cardiovascular Clinical Studies | ||||
| Verification Date | February 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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