Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
NCT ID: NCT01213368
Last Updated: 2013-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
181 participants
INTERVENTIONAL
2010-09-30
2011-04-30
Brief Summary
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\- 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
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* Screening period up to 7 days,
* Treatment period of 14 days,
* Follow-up period of 10 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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dronedarone 300 mg
Dronedarone, 100mg + 200mg tablets twice daily, administered with food.
DRONEDARONE (SR33589)
Pharmaceutical form: tablets
Route of administration: oral
dronedarone 400 mg
Dronedarone, 400mg tablets twice daily, administered with food.
DRONEDARONE (SR33589)
Pharmaceutical form: tablets
Route of administration: oral
dronedarone 600 mg
Dronedarone, 400mg + 200mg tablets twice daily, administered with food.
DRONEDARONE (SR33589)
Pharmaceutical form: tablets
Route of administration: oral
placebo
Matching placebo tablets twice daily, administered with food.
placebo
Pharmaceutical form: tablets
Route of administration: oral
Interventions
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DRONEDARONE (SR33589)
Pharmaceutical form: tablets
Route of administration: oral
placebo
Pharmaceutical form: tablets
Route of administration: oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 392022
Hiroshima, , Japan
Investigational Site Number 392018
Kagoshima, , 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, , Japan
Investigational Site Number 392013
Kobe, , Japan
Investigational Site Number 392003
Koriyama-Shi, , Japan
Investigational Site Number 392017
Kurume-Shi, , Japan
Investigational Site Number 392023
Miyazaki, , Japan
Investigational Site Number 392009
Nagano, , Japan
Investigational Site Number 392019
Nagasaki, , Japan
Investigational Site Number 392010
Osaka, , Japan
Investigational Site Number 392021
Sapporo, , Japan
Investigational Site Number 392025
Sapporo, , Japan
Investigational Site Number 392002
Sendai, , 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
Yakushi, , Japan
Countries
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Other Identifiers
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U1111-1116-9409
Identifier Type: OTHER
Identifier Source: secondary_id
DRI10939
Identifier Type: -
Identifier Source: org_study_id