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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: September 30, 2010
Last updated: October 12, 2013
Last verified: October 2013

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.

Condition Intervention Phase
Atrial Fibrillation
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG) [ Time Frame: Day 14 ]

Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: up to 10 days after last drug intake ]
  • Plasma trough concentrations for SR33589 [ Time Frame: Day 14 ]
  • Plasma trough concentrations for SR35021 [ Time Frame: Day 14 ]

Enrollment: 181
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dronedarone 300 mg
Dronedarone, 100mg + 200mg tablets twice daily, administered with food.

Pharmaceutical form: tablets

Route of administration: oral

Experimental: dronedarone 400 mg
Dronedarone, 400mg tablets twice daily, administered with food.

Pharmaceutical form: tablets

Route of administration: oral

Experimental: dronedarone 600 mg
Dronedarone, 400mg + 200mg tablets twice daily, administered with food.

Pharmaceutical form: tablets

Route of administration: oral

Placebo Comparator: placebo
Matching placebo tablets twice daily, administered with food.
Drug: placebo

Pharmaceutical form: tablets

Route of administration: oral

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.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT01213368

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, Japan
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT01213368     History of Changes
Other Study ID Numbers: DRI10939
U1111-1116-9409 ( Other Identifier: (UTN) )
Study First Received: September 30, 2010
Last Updated: October 12, 2013

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors processed this record on April 26, 2017