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

NCT01213368 | Completed Phase 2 DMC

• 2 other identifiers: DRI10939U1111-1116-9409
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 25

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

  Day 14

Secondary Outcomes (3)

• Number of patients with adverse events

  up to 10 days after last drug intake

• Plasma trough concentrations for SR33589

  Day 14

• Plasma trough concentrations for SR35021

  Day 14

Study Arms (4)

dronedarone 300 mg

EXPERIMENTAL

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

Drug: DRONEDARONE (SR33589)

dronedarone 400 mg

EXPERIMENTAL

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

Drug: DRONEDARONE (SR33589)

dronedarone 600 mg

EXPERIMENTAL

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

Drug: DRONEDARONE (SR33589)

placebo

PLACEBO COMPARATOR

Matching placebo tablets twice daily, administered with food.

Drug: placebo

Interventions

DRONEDARONE (SR33589) DRUG

Pharmaceutical form: tablets Route of administration: oral

dronedarone 300 mg; dronedarone 400 mg; dronedarone 600 mg

placebo DRUG

Pharmaceutical form: tablets Route of administration: oral

placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (25)

Investigational Site Number 392022

Hiroshima, Japan

Location

Investigational Site Number 392018

Kagoshima, Japan

Location

Investigational Site Number 392005

Kasama-Shi, Japan

Location

Investigational Site Number 392014

Kawanishi-Shi, Japan

Location

Investigational Site Number 392008

Kawasaki-Shi, Japan

Location

Investigational Site Number 392007

Kisarazu-Shi, Japan

Location

Investigational Site Number 392012

Kobe, Japan

Location

Investigational Site Number 392013

Kobe, Japan

Location

Investigational Site Number 392003

Koriyama-Shi, Japan

Location

Investigational Site Number 392017

Kurume-Shi, Japan

Location

Investigational Site Number 392023

Miyazaki, Japan

Location

Investigational Site Number 392009

Nagano, Japan

Location

Investigational Site Number 392019

Nagasaki, Japan

Location

Investigational Site Number 392010

Osaka, Japan

Location

Investigational Site Number 392021

Sapporo, Japan

Location

Investigational Site Number 392025

Sapporo, Japan

Location

Investigational Site Number 392002

Sendai, Japan

Location

Investigational Site Number 392004

Shirakawa-Shi, Japan

Location

Investigational Site Number 392016

Shunan-Shi, Japan

Location

Investigational Site Number 392020

Suwa-Shi, Japan

Location

Investigational Site Number 392006

Takasaki-Shi, Japan

Location

Investigational Site Number 392001

Tomakomai-Shi, Japan

Location

Investigational Site Number 392024

Toshima-Ku, Japan

Location

Investigational Site Number 392015

Ube-Shi, Japan

Location

Investigational Site Number 392011

Yakushi, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amiodarone; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

JP (25)