European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure (ANDROMEDA)
Primary Purpose
Congestive Heart Failure
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dronedarone (SR33589)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart disease, morbidity
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.
Sites / Locations
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dronedarone 400mg bid
Placebo
Arm Description
dronedarone 400mg tablets
matching placebo tablets
Outcomes
Primary Outcome Measures
Death from any cause or adjudicated hospitalization for worsening heart failure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00696631
Brief Title
European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure
Acronym
ANDROMEDA
Official Title
Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Terminated as the active treatment was associated with an increased hazard
Study Start Date
June 2002 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Heart disease, morbidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
653 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dronedarone 400mg bid
Arm Type
Experimental
Arm Description
dronedarone 400mg tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo tablets
Intervention Type
Drug
Intervention Name(s)
Dronedarone (SR33589)
Other Intervention Name(s)
Multaq®
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Death from any cause or adjudicated hospitalization for worsening heart failure
Time Frame
Until study cut-off date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-aventis Administrative Office
City
Lysaker
Country
Norway
Facility Name
Sanofi-aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-aventis Administrative Office
City
Bromma
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
18565860
Citation
Kober L, Torp-Pedersen C, McMurray JJ, Gotzsche O, Levy 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.
Results Reference
result
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European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure
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