Status:
COMPLETED
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
Lead Sponsor:
Sanofi
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 ...
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
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT01213368
Start Date
September 1 2010
End Date
April 1 2011
Last Update
October 16 2013
Active Locations (25)
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1
Investigational Site Number 392022
Hiroshima, Japan
2
Investigational Site Number 392018
Kagoshima, Japan
3
Investigational Site Number 392005
Kasama-Shi, Japan
4
Investigational Site Number 392014
Kawanishi-Shi, Japan