European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure

Phase 3 Terminated 653 enrolled Sanofi

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2002-06
Primary completion: 2003-01
Completion: 2003-08

Outcome

Missed primary endpoint

Stopped: “Terminated as the active treatment was associated with an increased hazard”

paper The primary end point did not differ significantly between the two groups PMID 18565860 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dronedarone	Small molecule	400 mg	—