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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213368
• Other study ID #: DRI10939
• Secondary ID: U1111-1116-9409
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2010
• Last updated: October 12, 2013
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: October 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• DRONEDARONE (SR33589)
Pharmaceutical form: tablets Route of administration: oral
• placebo
Pharmaceutical form: tablets Route of administration: oral

Locations

Country	Name	City	State
Japan	Investigational Site Number 392022	Hiroshima-Shi
Japan	Investigational Site Number 392018	Kagoshima-Shi
Japan	Investigational Site Number 392005	Kasama-Shi
Japan	Investigational Site Number 392014	Kawanishi-Shi
Japan	Investigational Site Number 392008	Kawasaki-Shi
Japan	Investigational Site Number 392007	Kisarazu-Shi
Japan	Investigational Site Number 392012	Kobe-Shi
Japan	Investigational Site Number 392013	Kobe-Shi
Japan	Investigational Site Number 392003	Koriyama-Shi
Japan	Investigational Site Number 392017	Kurume-Shi
Japan	Investigational Site Number 392023	Miyazaki-Shi
Japan	Investigational Site Number 392009	Nagano-Shi
Japan	Investigational Site Number 392019	Nagasaki-Shi
Japan	Investigational Site Number 392010	Osaka-Shi
Japan	Investigational Site Number 392021	Sapporo-Shi
Japan	Investigational Site Number 392025	Sapporo-Shi
Japan	Investigational Site Number 392002	Sendai-Shi
Japan	Investigational Site Number 392004	Shirakawa-Shi
Japan	Investigational Site Number 392016	Shunan-Shi
Japan	Investigational Site Number 392020	Suwa-Shi
Japan	Investigational Site Number 392006	Takasaki-Shi
Japan	Investigational Site Number 392001	Tomakomai-Shi
Japan	Investigational Site Number 392024	Toshima-Ku
Japan	Investigational Site Number 392015	Ube-Shi
Japan	Investigational Site Number 392011	Yao-Shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)		Day 14	No
Secondary	Number of patients with adverse events		up to 10 days after last drug intake	Yes
Secondary	Plasma trough concentrations for SR33589		Day 14	No
Secondary	Plasma trough concentrations for SR35021		Day 14	No