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

• ClinicalTrials.gov Identifier: NCT00696631
• Recruitment Status: Terminated
• First Posted: June 13, 2008
• Last Update Posted: February 15, 2010
• Sponsor: Sanofi
• Information provided by: Sanofi

Tracking Information

• First Submitted Date: June 12, 2008
• First Posted Date: June 13, 2008
• Last Update Posted Date: February 15, 2010
• Study Start Date: June 2002
• Actual Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 12, 2008): Death from any cause or adjudicated hospitalization for worsening heart failure [ Time Frame: Until study cut-off date ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure
• Official Title: Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Congestive Heart Failure

Intervention

• Drug: Dronedarone (SR33589)
  oral administration
  Other Name: Multaq®
• Drug: Placebo
  oral administration

Study Arms

• Experimental: Dronedarone 400mg bid
  dronedarone 400mg tablets
  Intervention: Drug: Dronedarone (SR33589)
• Placebo Comparator: Placebo
  matching placebo tablets
  Intervention: Drug: Placebo

• Publications *: Køber L, Torp-Pedersen C, McMurray JJ, Gøtzsche O, Lévy S, Crijns H, Amlie J, Carlsen J; Dronedarone Study Group. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med. 2008 Jun 19;358(25):2678-87. doi: 10.1056/NEJMoa0800456. Erratum in: N Engl J Med. 2010 Sep 30;363(14):1384.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 12, 2010): 653
• Original Actual Enrollment (submitted: June 12, 2008): 627
• Actual Study Completion Date: August 2003
• Actual Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, Hungary, Netherlands, Norway, Poland, Sweden

Administrative Information

• NCT Number: NCT00696631
• Other Study ID Numbers: EFC4966; SR33589
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: ICD Study Director, sanofi-aventis
• Study Sponsor: Sanofi
• Collaborators: Not Provided

Investigators

• Study Director: ICD; Sanofi

• PRS Account: Sanofi
• Verification Date: February 2010