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Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

NCT01151137 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3236

Last updated 2012-10-26

Study results available
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Summary

Primary Objective:

* Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additional risk factors

Secondary Objective:

* Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date \[CSED\] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

Conditions

Interventions

DRUG

Dronedarone

Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)

DRUG

Placebo (for Dronedarone)

film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

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 NCT01151137 on ClinicalTrials.gov