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European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure (ANDROMEDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00696631
Recruitment Status : Terminated (Terminated as the active treatment was associated with an increased hazard)
First Posted : June 13, 2008
Last Update Posted : February 15, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Dronedarone (SR33589) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 653 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease
Study Start Date : June 2002
Primary Completion Date : January 2003
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Dronedarone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dronedarone 400mg bid
dronedarone 400mg tablets
Drug: Dronedarone (SR33589)
oral administration
Other Name: Multaq®
Placebo Comparator: Placebo
matching placebo tablets
Drug: Placebo
oral administration

Primary Outcome Measures :
  1. Death from any cause or adjudicated hospitalization for worsening heart failure [ Time Frame: Until study cut-off date ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696631

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

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00696631     History of Changes
Obsolete Identifiers: NCT00543699
Other Study ID Numbers: EFC4966
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010

Keywords provided by Sanofi:
Heart disease

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors