Peroral Levosimendan in Chronic Heart Failure - Full Text View

Sponsored by:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00130884

Purpose

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.

Condition	Intervention	Phase
Chronic Heart Failure Heart Diseases	Drug: levosimendan	Phase II

MedlinePlus related topics: Heart Diseases Heart Failure

Drug Information available for: Levosimendan Simendan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Composite endpoint measuring symptoms, morbidity, mortality

Estimated Enrollment:	300
Study Start Date:	March 2005
Estimated Study Completion Date:	March 2006

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130884

Locations

Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Principal Investigator:

Markku S Nieminen, MD

Helsinki University Central Hospital, Finland

More Information

Study ID Numbers:	3001081
Study First Received:	August 15, 2005
Last Updated:	February 19, 2007
ClinicalTrials.gov Identifier:	NCT00130884
Health Authority:	Finland: National Agency for Medicines; Estonia: The State Agency of Medicine; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Orion Corporation, Orion Pharma:

levosimendan
chronic heart failure
oral administration

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Simendan

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Therapeutic Uses
Physiological Effects of Drugs

Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009