European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure (ANDROMEDA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00696631 |
|
Recruitment Status :
Terminated
(Terminated as the active treatment was associated with an increased hazard)
First Posted : June 13, 2008
Last Update Posted : February 15, 2010
|
Sponsor:
Sanofi
Information provided by:
Sanofi
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Congestive Heart Failure | Drug: Dronedarone (SR33589) Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 653 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease |
| Study Start Date : | June 2002 |
| Actual Primary Completion Date : | January 2003 |
| Actual Study Completion Date : | August 2003 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
Drug Information available for:
Dronedarone
| Arm | Intervention/treatment |
|---|---|
|
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 |
Primary Outcome Measures :
- Death from any cause or adjudicated hospitalization for worsening heart failure [ Time Frame: Until study cut-off date ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications of Results:
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00696631 |
| Obsolete Identifiers: | NCT00543699 |
| Other Study ID Numbers: |
EFC4966 SR33589 |
| First Posted: | June 13, 2008 Key Record Dates |
| Last Update Posted: | February 15, 2010 |
| Last Verified: | February 2010 |
Keywords provided by Sanofi:
|
Heart disease morbidity |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Dronedarone Anti-Arrhythmia Agents |