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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.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01213368
First received: September 30, 2010
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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: DRONEDARONE (SR33589)
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Dronedarone
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: up to 10 days after last drug intake ] [ Designated as safety issue: Yes ]
  • Plasma trough concentrations for SR33589 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Plasma trough concentrations for SR35021 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

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.
 Drug: DRONEDARONE (SR33589)

Pharmaceutical form: tablets

Route of administration: oral
Experimental: dronedarone 400 mg
Dronedarone, 400mg tablets twice daily, administered with food.
 Drug: DRONEDARONE (SR33589)

Pharmaceutical form: tablets

Route of administration: oral
Experimental: dronedarone 600 mg
Dronedarone, 400mg + 200mg tablets twice daily, administered with food.
 Drug: DRONEDARONE (SR33589)

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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213368

Locations
Japan
Sanofi-Aventis Investigational Site Number 392022
Hiroshima-Shi, Japan, 734-8530
Sanofi-Aventis Investigational Site Number 392018
Kagoshima-Shi, Japan, 892-0822
Sanofi-Aventis Investigational Site Number 392005
Kasama-Shi, Japan, 309-1793
Sanofi-Aventis Investigational Site Number 392014
Kawanishi-Shi, Japan, 666-0117
Sanofi-Aventis Investigational Site Number 392008
Kawasaki-Shi, Japan, 212-0021
Sanofi-Aventis Investigational Site Number 392007
Kisarazu-Shi, Japan, 292-8535
Sanofi-Aventis Investigational Site Number 392012
Kobe-Shi, Japan, 654-0026
Sanofi-Aventis Investigational Site Number 392013
Kobe-Shi, Japan, 657-0068
Sanofi-Aventis Investigational Site Number 392003
Koriyama-Shi, Japan, 963-8052
Sanofi-Aventis Investigational Site Number 392017
Kurume-Shi, Japan, 830-8577
Sanofi-Aventis Investigational Site Number 392023
Miyazaki-Shi, Japan, 880-0834
Sanofi-Aventis Investigational Site Number 392009
Nagano-Shi, Japan, 380-0814
Sanofi-Aventis Investigational Site Number 392019
Nagasaki-Shi, Japan, 850-8555
Sanofi-Aventis Investigational Site Number 392010
Osaka-Shi, Japan, 532-0003
Sanofi-Aventis Investigational Site Number 392025
Sapporo-Shi, Japan, 060-0011
Sanofi-Aventis Investigational Site Number 392021
Sapporo-Shi, Japan, 006-0811
Sanofi-Aventis Investigational Site Number 392002
Sendai-Shi, Japan, 981-3107
Sanofi-Aventis Investigational Site Number 392004
Shirakawa-Shi, Japan, 961-0005
Sanofi-Aventis Investigational Site Number 392016
Shunan-Shi, Japan, 745-8522
Sanofi-Aventis Investigational Site Number 392020
Suwa-Shi, Japan, 392-0027
Sanofi-Aventis Investigational Site Number 392006
Takasaki-Shi, Japan, 370-3513
Sanofi-Aventis Investigational Site Number 392001
Tomakomai-Shi, Japan, 053-8506
Sanofi-Aventis Investigational Site Number 392024
Toshima-Ku, Japan, 171-0021
Sanofi-Aventis Investigational Site Number 392015
Ube-Shi, Japan, 755-0151
Sanofi-Aventis Investigational Site Number 392011
Yao-Shi, Japan, 581-0036
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01213368     History of Changes
Other Study ID Numbers: DRI10939, U1111-1116-9409
Study First Received: September 30, 2010
Last Updated: July 16, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013