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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

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart disease, morbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT00696631

First Posted

June 12, 2008

Last Updated

February 12, 2010

Sponsor

Sanofi

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

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