atrial fibrillation MedDRA version: 12.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation MedDRA version: 12.1 Level: PT Classification code 10003658 Term: Atrial fibrillation
Conditions
Interventions
Trade Name: Multaq
Product Name: Multaq
Product Code: Multaq
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DRONEDARONE
CAS Number: 141626360
Concentration unit: mg milligram(s)
Concentr
Sponsors
sanofi-aventis Netherlands
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Paroxysmal or persistent AF (according to ACC/AHA/ESC 2006 definition) with HR >80 bpm at rest despite treatment with =2 rate control agents (i.e. beta blocker and/or calcium antagonist). Patients using digoxin are eligible. • Documented AF at randomisation or documented AF in the past 24 hours. • Treated with the following rate control medication: - beta blocker or - calcium antagonist or - beta blocker plus calcium antagonist or - beta blocker plus digoxin or - calcium antagonist plus digoxin. • > 45 years of age. • Anticoagulant treatment in line with local guidelines. 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Incapacitated patients. • Permanent AF (according to ACC/AHA/ESC 2006 definition). • Use of class I or III AADs. • Patients scheduled for cardioversion or pulmonary vein ablation. • Unstable NYHA class III and all class IV HF. • AV block grade 2 or 3. • Known severe renal impairment (serum creatinine >180 µmol/l). • Known severe hepatic impairment (AST, ALT >3x ULN). • Contra-indication for dronedarone. • Participation in a clinical drug study in the 3 months prior to inclusion. • Women of childbearing potential, who do not use adequate contraception (in the opinion of the investigator). • Lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the addition of dronedarone (Multaq®) to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high HR at rest during AF in comparison to an increase of conventional therapy.;Secondary Objective: To compare both study arms with regard to: - Ventricular rate after 3 months. - Number of registered AF episodes. - Number of symptomatic AF episodes. - Severity of AF and AF-like symptoms. - Adverse events. - Rate of premature study discontinuation (“going off study prematurely”). - Number of symptomatic episodes of bradycardia. - Incidence of low heart rate (<60 bpm).;Primary end point(s): Ventricular rate after 1 week. | — |
Countries
Netherlands
Outcome results
None listed