search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
DRONEDARONE (SR33589)
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 392022
  • Investigational Site Number 392018
  • Investigational Site Number 392005
  • Investigational Site Number 392014
  • Investigational Site Number 392008
  • Investigational Site Number 392007
  • Investigational Site Number 392012
  • Investigational Site Number 392013
  • Investigational Site Number 392003
  • Investigational Site Number 392017
  • Investigational Site Number 392023
  • Investigational Site Number 392009
  • Investigational Site Number 392019
  • Investigational Site Number 392010
  • Investigational Site Number 392021
  • Investigational Site Number 392025
  • Investigational Site Number 392002
  • Investigational Site Number 392004
  • Investigational Site Number 392016
  • Investigational Site Number 392020
  • Investigational Site Number 392006
  • Investigational Site Number 392001
  • Investigational Site Number 392024
  • Investigational Site Number 392015
  • Investigational Site Number 392011

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

dronedarone 300 mg

dronedarone 400 mg

dronedarone 600 mg

placebo

Arm Description

Dronedarone, 100mg + 200mg tablets twice daily, administered with food.

Dronedarone, 400mg tablets twice daily, administered with food.

Dronedarone, 400mg + 200mg tablets twice daily, administered with food.

Matching placebo tablets twice daily, administered with food.

Outcomes

Primary Outcome Measures

Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)

Secondary Outcome Measures

Number of patients with adverse events
Plasma trough concentrations for SR33589
Plasma trough concentrations for SR35021

Full Information

First Posted
September 30, 2010
Last Updated
October 12, 2013
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT01213368
Brief Title
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dronedarone 300 mg
Arm Type
Experimental
Arm Description
Dronedarone, 100mg + 200mg tablets twice daily, administered with food.
Arm Title
dronedarone 400 mg
Arm Type
Experimental
Arm Description
Dronedarone, 400mg tablets twice daily, administered with food.
Arm Title
dronedarone 600 mg
Arm Type
Experimental
Arm Description
Dronedarone, 400mg + 200mg tablets twice daily, administered with food.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets twice daily, administered with food.
Intervention Type
Drug
Intervention Name(s)
DRONEDARONE (SR33589)
Intervention Description
Pharmaceutical form: tablets Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Pharmaceutical form: tablets Route of administration: oral
Primary Outcome Measure Information:
Title
Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Number of patients with adverse events
Time Frame
up to 10 days after last drug intake
Title
Plasma trough concentrations for SR33589
Time Frame
Day 14
Title
Plasma trough concentrations for SR35021
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392022
City
Hiroshima-Shi
Country
Japan
Facility Name
Investigational Site Number 392018
City
Kagoshima-Shi
Country
Japan
Facility Name
Investigational Site Number 392005
City
Kasama-Shi
Country
Japan
Facility Name
Investigational Site Number 392014
City
Kawanishi-Shi
Country
Japan
Facility Name
Investigational Site Number 392008
City
Kawasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392007
City
Kisarazu-Shi
Country
Japan
Facility Name
Investigational Site Number 392012
City
Kobe-Shi
Country
Japan
Facility Name
Investigational Site Number 392013
City
Kobe-Shi
Country
Japan
Facility Name
Investigational Site Number 392003
City
Koriyama-Shi
Country
Japan
Facility Name
Investigational Site Number 392017
City
Kurume-Shi
Country
Japan
Facility Name
Investigational Site Number 392023
City
Miyazaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392009
City
Nagano-Shi
Country
Japan
Facility Name
Investigational Site Number 392019
City
Nagasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392010
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392021
City
Sapporo-Shi
Country
Japan
Facility Name
Investigational Site Number 392025
City
Sapporo-Shi
Country
Japan
Facility Name
Investigational Site Number 392002
City
Sendai-Shi
Country
Japan
Facility Name
Investigational Site Number 392004
City
Shirakawa-Shi
Country
Japan
Facility Name
Investigational Site Number 392016
City
Shunan-Shi
Country
Japan
Facility Name
Investigational Site Number 392020
City
Suwa-Shi
Country
Japan
Facility Name
Investigational Site Number 392006
City
Takasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392001
City
Tomakomai-Shi
Country
Japan
Facility Name
Investigational Site Number 392024
City
Toshima-Ku
Country
Japan
Facility Name
Investigational Site Number 392015
City
Ube-Shi
Country
Japan
Facility Name
Investigational Site Number 392011
City
Yao-Shi
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs