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| Sponsor: | Abbott |
|---|---|
| Collaborator: |
Orion Corporation, Orion Pharma |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00048425 |
Purpose
The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure, Congestive |
Drug: Levosimendan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study. |
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | December 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following criteria would exclude the patient from study:
Contacts and Locations
Show 166 Study Locations| Study Director: | Scott Krause | Abbott |
More Information
| ClinicalTrials.gov Identifier: | NCT00048425 History of Changes |
| Other Study ID Numbers: | 3001069 |
| Study First Received: | October 31, 2002 |
| Last Updated: | December 14, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Decompensated chronic heart failure |
|
Heart Failure Heart Diseases Cardiovascular Diseases Simendan Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Cardiotonic Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Protective Agents Physiological Effects of Drugs |