Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure (ANDROMEDA)
This study has been terminated.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00696631
  Purpose

The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone versus placebo in patients with symptomatic congestive heart failure (CHF) and left ventricular dysfunction (LVD) when added to evidence based treatments for CHF.


Condition Intervention Phase
Congestive Heart Failure
Drug: Dronedarone (SR33589)
Drug: Placebo
Phase III

MedlinePlus related topics: Heart Failure
Drug Information available for: Dronedarone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Death from any cause or adjudicated hospitalization for worsening heart failure [ Time Frame: Until study cut-off date ] [ Designated as safety issue: No ]

Enrollment: 627
Study Start Date: June 2002
Study Completion Date: August 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Dronedarone (SR33589)
400 mg tablets bid
2: Placebo Comparator Drug: Placebo
matching placebo tablets

  Eligibility

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

Inclusion Criteria:

  • Patients hospitalized with symptomatic CHF, current New York Heart Association (NYHA) class II-IV requiring treatment with a diuretic, who had had within the last month at least 1 episode of dyspnea or fatigue at rest, or on slight exertion corresponding to NYHA class III or IV
  • Wall motion index (WMI) ≤1.2 determined by a blinded central evaluation of a recorded standard echocardiography, equivalent to a left ventricular ejection fraction (LVEF) ≤35%.

Exclusion Criteria:

  • acute pulmonary edema within 12 hours prior to start of study medication
  • various heart conditions (cardiogenic shock, obstructive valvular disease, obstructive cardiomyopathy; acute myocardial infarction, cardiac surgery, acute myocarditis or constrictive pericarditis, history of torsades de pointes, bradycardia <50 bpm and/or PR-interval ≥280 ms, QTc-interval >500 ms, significant sinus node disease)
  • any illness or disorder other than CHF (cancer with metastasis, organ transplantation)
  • current participation in another clinical study or currently taking an investigational drug including dronedarone or concomitant prohibited medication or treatment with other class I or III anti-arrhythmic drugs
  • pregnant and/or breastfeeding women or women of child-bearing potential without adequate birth control
  • serum potassium <3.5 mmol/L.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696631

Locations
Denmark
Sanofi-aventis Administrative Office
Horsholm, Denmark
Hungary
Sanofi-aventis Administrative Office
Budapest, Hungary
Netherlands
Sanofi-aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-aventis Administrative Office
Lysaker, Norway
Poland
Sanofi-aventis Administrative Office
Warszawa, Poland
Sweden
Sanofi-aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD Sanofi-Aventis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC4966, SR33589
Study First Received: June 12, 2008
Last Updated: June 12, 2008
ClinicalTrials.gov Identifier: NCT00696631  
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Sanofi-Aventis:
Heart disease
morbidity

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009