Efficacy and safety of amiodarone 100mg versus 200mg for the maintenance of sinus rhythm after cardioversion of atrial fibrillation

INTERVENTION: Trade Name: Cordarone X 100 Cordarone X 200 Product Name: Amiodarone/Cordarone X 100/Cordarone X 200 Pharmaceutical Form: Tablet INN or Proposed INN: AMIODARONE HYDROCHLORIDE CAS Number: 19774824 Current Sponsor code: C02.001 Other descriptive name: Cordarone X 100 Cordarone 200 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 100‐200 CONDITION: Atrial fibrillation PRIMARY OUTCOME: Main Objective: comparing 2 doses of one drug for the maintenance of sinus rhythm after DC cardioversion Primary end point(s): maintenance of sinus rhythma Secondary Objective: comparing 2 doses of one drug with respect to side effects INCLUSION CRITERIA: atrial fibrillation 30 days to year duration 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