EUCTR2010-018976-25-BE
Active, not recruiting
Not Applicable
An open label non-controlled trial to evaluate the effect of dronedarone (Multaq® 400 mg BID) on the quality of life in patiënts with a history of, or current non-permanent atrial fibrillation (AF) - HEMERA
sanofi-aventis Belgium0 sitesJune 10, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- sanofi-aventis Belgium
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinically stable patients with a history of, or current, symptomatic non\-permanent Atrial Fibrillation (AF) in whom anti\-arrhythmic treatment is indicated
- •Patients able to understand the patient information leaflet and sign the Informed Consent form for this study protocol
- •Patients aged \= 18 years
- •Documented AF within the last 6 months prior to inclusion or at the time of inclusion
- •Documented sinus rhythm within the last 6 months prior to inclusion or at the time of inclusion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Criteria stated in the Summary of Product Characteristics
- •\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-
- •Hypersensitivity to the active substance or to any of the excipients
- •Second\- or third\-degree atrio\-ventricular block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
- •Bradycardia \< 50 beats per minute (bpm)
- •Patients in unstable hemodynamic conditions including patients with symptoms of heart failure at rest or with minimal exertion (corresponding to NYHA class IV and unstable class III patients)
- •Co\-administration with potent cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone, and ritonavir
- •Usage of medicinal products inducing torsade de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine, and certain oral macrolides, class I and III anti\-arrhythmics
- •QTc Bazett interval \= 500 milliseconds
- •Severe hepatic impairment
Outcomes
Primary Outcomes
Not specified
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