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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01213368
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: DRONEDARONE (SR33589) Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : September 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dronedarone

Arm Intervention/treatment
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





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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213368


Locations
Show Show 25 study locations
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01213368    
Other Study ID Numbers: DRI10939
U1111-1116-9409 ( Other Identifier: (UTN) )
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dronedarone
Anti-Arrhythmia Agents