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Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation

NCT01070667 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-02-22

No results posted yet for this study

Summary

The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compared with placebo. This has never previously been performed using pacemaker Holter monitoring which provides detailed information of atrial arrhythmia patterns the entire study period. Additionally detailed patient symptom self assessment and questionnaires will be collected. The study design will be double blinded crossover with each phase lasting 3 months.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DRUG

Dronedarone

400mg orally once per day for 3 months

DRUG

Placebo

1 tablet once per day for 3 months. The tablet will appear identical to the active dronedarone tablet.

Sponsors & Collaborators

  • Eastbourne General Hospital

    lead OTHER

Principal Investigators

  • A N Sulke, MD · East Sussex NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01070667 on ClinicalTrials.gov