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NCT00130884 Clinical Trial

Peroral Levosimendan in Chronic Heart Failure

Heart Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00130884
Other study ID # 3001081
Secondary ID
Status Completed
Phase Phase 2
First received August 15, 2005
Last updated February 19, 2007
Start date March 2005
Est. completion date March 2006

Study information
Verified date February 2007
Source Orion Corporation, Orion Pharma
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines AgencyEstonia: The State Agency of MedicineLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthRussia: Pharmacological Committee, Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• levosimendan

Locations
Country Name City State
Finland Helsinki University Central Hospital Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite endpoint measuring symptoms, morbidity, mortality
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