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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00130884     History of Changes
Other Study ID Numbers: 3001081
Study First Received: August 15, 2005
Last Updated: February 19, 2007
Health Authority: Finland: Finnish Medicines Agency
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

Additional relevant MeSH terms:
Heart Diseases
Heart Failure
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014