Peroral Levosimendan in Chronic Heart Failure - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 15, 2005

Last Updated Date

February 19, 2007

Start Date ^†

March 2005

Current Primary Outcome Measures ^†

Composite endpoint measuring symptoms, morbidity, mortality

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00130884 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Peroral Levosimendan in Chronic Heart Failure

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

Brief 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.

Detailed Description

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Chronic Heart Failure
Heart Diseases

Intervention ^†

Drug: levosimendan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

300

Completion Date

March 2006

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Finland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00130884

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Orion Corporation, Orion Pharma

Collaborators ^††

Investigators ^†

Principal Investigator:

Markku S Nieminen, MD

Helsinki University Central Hospital, Finland

Information Provided By

Orion Corporation, Orion Pharma

Verification Date

February 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.