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Terminated Phase 4 Interventional Results available

Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

ClinicalTrials.gov ID: NCT01135017

Public ClinicalTrials.gov record NCT01135017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 31, 2026, 8:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Dronedarone 400 mg BID for 12 Weeks on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker. Secondary objectives were to evaluate: * the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF; * the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS); * the incidence of electrical cardioversion (or overdrive pacing) during treatment; * the safety of dronedarone.

Study identification

NCT ID
NCT01135017
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
Sanofi
Industry
Enrollment
112 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2010 (Type not available)
Primary completion
Feb 2012 (Actual)
Completion
Feb 2012 (Actual)
Last update posted
Apr 11, 2013

2010 – 2012

United States locations

U.S. sites
92
U.S. states
33
U.S. cities
82
Facility City State ZIP Site status
Investigational Site Number 840015 Birmingham Alabama 35235 —
Investigational Site Number 840087 Huntsville Alabama 35801 —
Investigational Site Number 840018 Mobile Alabama 36608 —
Investigational Site Number 840030 Mesa Arizona 85206 —
Investigational Site Number 840048 Phoenix Arizona 85006 —
Investigational Site Number 840072 Phoenix Arizona 85032 —
Investigational Site Number 840013 Tucson Arizona 85723 —
Investigational Site Number 840069 Hot Springs Arkansas 71913 —
Investigational Site Number 840121 Beverly Hills California 90211 —
Investigational Site Number 840090 Laguna Hills California 92653 —
Investigational Site Number 840068 Los Angeles California 90048 —
Investigational Site Number 840062 Mission Hills California 91345 —
Investigational Site Number 840070 Orange California 92868 —
Investigational Site Number 840021 Riverside California 92501 —
Investigational Site Number 840024 San Diego California 92103 —
Investigational Site Number 840001 Aurora Colorado 80012 —
Investigational Site Number 840089 Littleton Colorado 80120 —
Investigational Site Number 840029 Loveland Colorado 80538 —
Investigational Site Number 840108 Newark Delaware 19713 —
Investigational Site Number 840045 Washington D.C. District of Columbia 20010-2975 —
Investigational Site Number 840106 Washington D.C. District of Columbia 20037 —
Investigational Site Number 840010 Clearwater Florida 33756 —
Investigational Site Number 840020 Fort Myers Florida 33908 —
Investigational Site Number 840058 Inverness Florida 34452 —
Investigational Site Number 840043 Jacksonville Florida 32204 —
Investigational Site Number 840066 Jacksonville Florida 32216 —
Investigational Site Number 840128 Jacksonville Florida 32216 —
Investigational Site Number 840044 Jacksonville Beach Florida 32250 —
Investigational Site Number 840042 Orlando Florida 32803 —
Investigational Site Number 840016 Port Charlotte Florida 33952 —
Investigational Site Number 840080 Wellington Florida 33449 —
Investigational Site Number 840056 Gainesville Georgia 30501 —
Investigational Site Number 840092 Normal Illinois 61761 —
Investigational Site Number 840032 Oak Lawn Illinois 60453 —
Investigational Site Number 840046 Rockford Illinois 61107 —
Investigational Site Number 840051 Bloomington Indiana 47403 —
Investigational Site Number 840053 Kansas City Kansas 66160 —
Investigational Site Number 840110 Owensboro Kentucky 42303 —
Investigational Site Number 840102 Columbia Maryland 21044 —
Investigational Site Number 840017 Lansing Michigan 48910 —
Investigational Site Number 840081 Lapeer Michigan 48446 —
Investigational Site Number 840075 Petoskey Michigan 49770 —
Investigational Site Number 840027 Troy Michigan 48085 —
Investigational Site Number 840104 Saint Cloud Minnesota 56301 —
Investigational Site Number 840097 Tupelo Mississippi 38801 —
Investigational Site Number 840037 Columbia Missouri 65212 —
Investigational Site Number 840035 Kansas City Missouri 64111 —
Investigational Site Number 840060 St Louis Missouri 63122 —
Investigational Site Number 840055 St Louis Missouri 63141 —
Investigational Site Number 840067 Missoula Montana 59802 —
Investigational Site Number 840049 Reno Nevada 89502 —
Investigational Site Number 840054 Reno Nevada 89502 —
Investigational Site Number 840026 Bridgewater New Jersey 08807 —
Investigational Site Number 840093 Englewood New Jersey 07631 —
Investigational Site Number 840006 Buffalo New York 14215 —
Investigational Site Number 840077 Kingston New York 12401 —
Investigational Site Number 840096 Mineola New York 11501 —
Investigational Site Number 840041 Syracuse New York 13202 —
Investigational Site Number 840036 The Bronx New York 10467 —
Investigational Site Number 840086 Troy New York 12180 —
Investigational Site Number 840007 Williamsville New York 14221 —
Investigational Site Number 840084 Raleigh North Carolina 27610 —
Investigational Site Number 840061 Wilmington North Carolina 28401 —
Investigational Site Number 840065 Tulsa Oklahoma 74104 —
Investigational Site Number 840008 Camp Hill Pennsylvania 17011 —
Investigational Site Number 840009 Doylestown Pennsylvania 18901 —
Investigational Site Number 840004 Philadelphia Pennsylvania 19111 —
Investigational Site Number 840078 Phoenixville Pennsylvania 19460 —
Investigational Site Number 840105 Pittsburgh Pennsylvania 15236 —
Investigational Site Number 840130 Scranton Pennsylvania 18510 —
Investigational Site Number 840019 Unionville Pennsylvania 15401 —
Investigational Site Number 840023 Wyomissing Pennsylvania 19610 —
Investigational Site Number 840119 Greenville South Carolina 29607 —
Investigational Site Number 840002 Rapid City South Dakota 57701 —
Investigational Site Number 840114 Germantown Tennessee 38138 —
Investigational Site Number 840118 Corpus Christi Texas 78404 —
Investigational Site Number 840014 Dallas Texas 75390-8858 —
Investigational Site Number 840012 San Antonio Texas 78229 —
Investigational Site Number 840125 Tyler Texas 75701 —
Investigational Site Number 840083 Salt Lake City Utah 84102 —
Investigational Site Number 840113 Danville Virginia 24541 —
Investigational Site Number 840082 Lynchburg Virginia 24501 —
Investigational Site Number 840088 Manassas Virginia 20109 —
Investigational Site Number 840099 Richmond Virginia 23219 —
Investigational Site Number 840112 Richmond Virginia 23230 —
Investigational Site Number 840003 Tacoma Washington 98405 —
Investigational Site Number 840107 Tacoma Washington 98405 —
Investigational Site Number 840123 Green Bay Wisconsin 54301-3505 —
Investigational Site Number 840022 Madison Wisconsin 53713 —
Investigational Site Number 840033 Milwaukee Wisconsin 53215 —
Investigational Site Number 840047 Milwaukee Wisconsin 53215 —
Investigational Site Number 840076 Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01135017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 11, 2013 · Synced Oct 31, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01135017 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →