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Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation

NCT01199081 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2013-06-07

No results posted yet for this study

Summary

Primary Objective:

\- Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.

Secondary Objective:

* Explore potential PK interaction between Dronedarone and Amiodarone
* Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after)
* To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety

Conditions

Interventions

DRUG

Dronedarone

Pharmaceutical form: tablet Route of administration: oral (together with meal) Dose regimen: 400 mg twice daily

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Mexico
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01199081 on ClinicalTrials.gov