Clinical trial NCT01213368: Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
Official title: Double Blind, Randomized, Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Dronedarone (SR33589B) at 300, 400, or 600 mg BID for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 181
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)
timeFrame: Day 14
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 10 days after last drug intake
measure: Plasma trough concentrations for SR33589
timeFrame: Day 14
measure: Plasma trough concentrations for SR35021
timeFrame: Day 14
Other outcomes:
Locations:
city: Hiroshima-Shi
country: Japan
facility: Investigational Site Number 392022
city: Kagoshima-Shi
country: Japan
facility: Investigational Site Number 392018
city: Kasama-Shi
country: Japan
facility: Investigational Site Number 392005
city: Kawanishi-Shi
country: Japan
facility: Investigational Site Number 392014
city: Kawasaki-Shi
country: Japan
facility: Investigational Site Number 392008
city: Kisarazu-Shi
country: Japan
facility: Investigational Site Number 392007
city: Kobe-Shi
country: Japan
facility: Investigational Site Number 392012
city: Kobe-Shi
country: Japan
facility: Investigational Site Number 392013
city: Koriyama-Shi
country: Japan
facility: Investigational Site Number 392003
city: Kurume-Shi
country: Japan
facility: Investigational Site Number 392017
city: Miyazaki-Shi
country: Japan
facility: Investigational Site Number 392023
city: Nagano-Shi
country: Japan
facility: Investigational Site Number 392009
city: Nagasaki-Shi
country: Japan
facility: Investigational Site Number 392019
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392010
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392021
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392025
city: Sendai-Shi
country: Japan
facility: Investigational Site Number 392002
city: Shirakawa-Shi
country: Japan
facility: Investigational Site Number 392004
city: Shunan-Shi
country: Japan
facility: Investigational Site Number 392016
city: Suwa-Shi
country: Japan
facility: Investigational Site Number 392020
city: Takasaki-Shi
country: Japan
facility: Investigational Site Number 392006
city: Tomakomai-Shi
country: Japan
facility: Investigational Site Number 392001
city: Toshima-Ku
country: Japan
facility: Investigational Site Number 392024
city: Ube-Shi
country: Japan
facility: Investigational Site Number 392015
city: Yao-Shi
country: Japan
facility: Investigational Site Number 392011
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: