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

This study has been terminated.
(Terminated as the active treatment was associated with an increased hazard)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00696631
First received: June 12, 2008
Last updated: February 12, 2010
Last verified: February 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease

Resource links provided by NLM:


Further study details as provided by Sanofi:

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: 653
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
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

  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
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, see Learn About Clinical Studies.

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
Investigators
Study Director: ICD Sanofi
  More Information

Publications:
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00696631     History of Changes
Obsolete Identifiers: NCT00543699
Other Study ID Numbers: EFC4966, SR33589
Study First Received: June 12, 2008
Last Updated: February 12, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Sanofi:
Heart disease
morbidity

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014