Status:
TERMINATED
European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure
Lead Sponsor:
Sanofi
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
653 Patients enrolled
Trial Details
Trial ID
NCT00696631
Start Date
June 1 2002
End Date
August 1 2003
Last Update
February 15 2010
Active Locations (6)
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1
Sanofi-aventis Administrative Office
Hørsholm, Denmark
2
Sanofi-aventis Administrative Office
Budapest, Hungary
3
Sanofi-aventis Administrative Office
Gouda, Netherlands
4
Sanofi-aventis Administrative Office
Lysaker, Norway