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Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement

NCT01198873 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2013-02-12

Study results available
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Summary

Primary Objective:

\- Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the progression of adverse left atrial remodeling in patients with atrial fibrillation (AF) following 12 months of treatment.

Secondary Objectives:

* Evaluate the effects of dronedarone versus placebo on left atrial function;
* Evaluate the effects of dronedarone versus placebo on left atrial dimension;
* Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF, E, E', A, E/E')
* Evaluate the safety and tolerability of dronedarone.

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
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • Canada

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 NCT01198873 on ClinicalTrials.gov