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| Sponsor: | Abbott |
|---|---|
| Collaborator: |
Orion Corporation, Orion Pharma |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00348504 |
Purpose
The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Heart Failure |
Drug: levosimendan Drug: dobutamine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure. |
| Estimated Enrollment: | 1300 |
| Study Start Date: | March 2003 |
| Study Completion Date: | June 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical need for intravenous inotropic support as evidenced by insufficient response to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at least one of the following at screening:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Global Medical Information - Abbott | |
| Abbott Park, Illinois, United States, 60064 | |
| Study Director: | Robert J Padley, M.D. | Abbott |
More Information
| ClinicalTrials.gov Identifier: | NCT00348504 History of Changes |
| Other Study ID Numbers: | 3001077 |
| Study First Received: | June 30, 2006 |
| Last Updated: | November 16, 2007 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Heart Failure Heart Diseases Cardiovascular Diseases Simendan Dobutamine Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Anti-Arrhythmia Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Vasodilator Agents |