Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation

Sanofi

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: placebo; Drug: DRONEDARONE (SR33589)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01213368

U1111-1116-9409 (Other Identifier)

DRI10939

Details and patient eligibility

About

Primary Objective:

• To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF).

Secondary Objective:

• To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population.
• To document SR33589 and SR35021 trough plasma levels at steady state.

Full description

The study period per patient is approximatively 1 month broken down as follows:

• Screening period up to 7 days,
• Treatment period of 14 days,
• Follow-up period of 10 days.

Enrollment: 181 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of aged 20 years or more.
• Permanent Atrial Fibrillation [AF] (defined as duration of AF > 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening.

Exclusion criteria

• Unstable angina pectoris.
• History of torsades de pointes.
• Prolonged QT corrected interval (≥ 500 ms).
• Third degree atrioventricular block (AVB) on the screening ECG while in AF or, documentation on previous ECGs while in sinus rhythm of PR-interval > 0.28 sec or high degree AVB (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted.
• Congestive Heart Failure (CHF) of New York Heart Association classification (NYHA) class IV or recent (within 1 month prior to randomization) unstable NYHA class III.
• Treatment with other class I or III anti-arrhythmic drugs.
• Patients treated with amiodarone during the 4 weeks preceding randomization.
• Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic (in particular thyroid) or psychiatric disease.
• Hypokalemia and hypomagnesemia must be corrected before randomization.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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181 participants in 4 patient groups, including a placebo group

dronedarone 300 mg

Experimental group

Description:

Dronedarone, 100mg + 200mg tablets twice daily, administered with food.

Treatment:

Drug: DRONEDARONE (SR33589)

dronedarone 400 mg

Experimental group

Description:

Dronedarone, 400mg tablets twice daily, administered with food.

Treatment:

Drug: DRONEDARONE (SR33589)

dronedarone 600 mg

Experimental group

Description:

Dronedarone, 400mg + 200mg tablets twice daily, administered with food.

Treatment:

Drug: DRONEDARONE (SR33589)

placebo

Placebo Comparator group

Description:

Matching placebo tablets twice daily, administered with food.

Treatment:

Drug: placebo