Placebo controlled double blind dose ranging study of the efficacy and safety of SSR149744C 50, 100, 200, or 300 mg OD, with amiodarone as calibrator for the maintenance of sinus rhythm in patients with recent atrial fibrillation/flutter. - MAIA

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2004-001766-40-SE
• Date of registration: 19/10/2004
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Synthelabo Recherche
• Public title: Placebo controlled double blind dose ranging study of the efficacy and safety of SSR149744C 50, 100, 200, or 300 mg OD, with amiodarone as calibrator for the maintenance of sinus rhythm in patients with recent atrial fibrillation/flutter. - MAIA
• Scientific title: Placebo controlled double blind dose ranging study of the efficacy and safety of SSR149744C 50, 100, 200, or 300 mg OD, with amiodarone as calibrator for the maintenance of sinus rhythm in patients with recent atrial fibrillation/flutter. - MAIA
• Date of first enrolment: 24/01/2005
• Target sample size: 660
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001766-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: Amiodarone used as calibrator

Countries of recruitment

Denmark, Germany, Hungary, Italy, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Patients with documented sinus rhythm for at least 1 hour at the time of randomization (two 12-lead ECGs at least 1 hour apart and both showing sinus rhythm on the day of randomization must be available);
With at least one 12-lead ECG documented AF/AFL apisode in the last 3 months.
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:
Patients of either sex aged below 21 years;
Women of chibearing potential without adequate birthcontrol;
Pregnant women; Breastfeeding women.

Unstable angina pectoris;
Documented AF/AFL episode motivating inclusion in the study starting and not persisting beyond 10 days after an acute condition known to cause AF/AFL;
History of torsade de pointe;
Congenital long QT syndrome;
QT syndrome up to 500 msec;
Family history of sudden cardiac death below age 50 years in the absence of coronary heart disease;
Wolff-Parkinson-White syndrome;
History of high degree atrio-ventricular block or significant sinus node disease without a permanent pacemaker implanted.

Patients in whom amiodarone prescribed for sinus rhythm maintenance was dicontinued for inefficacy;
Patients in whom 3 or more class 1 or 3 antiarrhythmic drugs prescribed for sinus rhythm maintenance were discontinuated for inefficacy.

Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease.

patients for whom the washout requirements for previous amiodarone treatment cannot be respected;
Patients in whom a contra-indicated concomitant treatment is mandatory (drug which can cause torsade de pointe);
Treatment with other class 1 or 3 antiarrhythmic drugs which cannot be discontinuated with the required washout period before the first study drug administration.

Hyperthyroïdism;
Hypothyroïdism;
Other contra-indications to amiodarone.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Atrial fibrillation/flutter
MedDRA version: 7.0 Level: PT Classification code 10003658

Intervention(s)

Product Code: SSR149744C
Pharmaceutical Form: Capsule*
CAS Number: 401925-44-8
Current Sponsor code: SSR149744C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Code: SSR149744C
Pharmaceutical Form: Capsule*
CAS Number: 401925-44-8
Current Sponsor code: SSR149744C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: Amiodarone
Pharmaceutical Form: Capsule*
INN or Proposed INN: Amiodarone
CAS Number: 1951-25-3
Current Sponsor code: L3428
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To assess the efficacy of SSR149744C versus placebo on symptomatic AF/AFL recurrence and AF/AFL related symptoms.
To assess versus placebo the ventricular rate during the first AF/AFL episode in the different SSR149744C groups in case of AF/AFL recurrence.

To assess versus placebo the tolerability of the different dose regimens of SSR149744C.
Document SSR149744C plasma levels.

Primary end point(s): Time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECGs or TTEM tracings showing AF/AFL.

Main Objective: To evaluate the efficacy of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

Secondary ID(s)

2004-001766-40-HU

DRI5165