Peroral Levosimendan in Chronic Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00130884
First received: August 15, 2005
Last updated: February 19, 2007
Last verified: February 2007

August 15, 2005
February 19, 2007
March 2005
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Composite endpoint measuring symptoms, morbidity, mortality
Same as current
Complete list of historical versions of study NCT00130884 on ClinicalTrials.gov Archive Site
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Peroral Levosimendan in Chronic Heart Failure
Effects of Peroral Levosimendan in the Prevention of Further Hospitalisations in Patients With Chronic Heart Failure. A Randomised, Phase II, Double-Blind, Placebo-Controlled, Multi-Centre, Parallel-Group Study

The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months.

The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Chronic Heart Failure
  • Heart Diseases
Drug: levosimendan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
March 2006
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Inclusion Criteria:

  • Diagnosed chronic heart failure
  • Severe symptoms (NYHA IIIb-IV)
  • Optimal on-going oral treatment for HF
  • Left ventricular ejection fraction less than or equal to 30%

Exclusion Criteria:

  • Severe obstruction of ventricular outflow tracts
  • Acute myocardial infarction within 30 days before screening
  • Cardiac surgery or coronary angioplasty within 30 days before screening
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00130884
3001081
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Orion Corporation, Orion Pharma
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Principal Investigator: Markku S Nieminen, MD Helsinki University Central Hospital, Finland
Orion Corporation, Orion Pharma
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP