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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. 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

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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
Actual Primary Completion Date : January 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Dronedarone

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

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 identifier (NCT number): NCT00696631

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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
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Study Director: ICD Sanofi
Publications of Results:
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00696631    
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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents