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Completed Phase 2 Interventional

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

ClinicalTrials.gov ID: NCT00993382

Public ClinicalTrials.gov record NCT00993382. 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 Sep 5, 2026, 3:05 PM EDT

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

Official title

Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Celivarone at 50, 100 or 300 mg OD With Amiodarone as Calibrator for the Prevention of ICD Interventions or Death

Brief summary

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

The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary objectives were: * To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population. * To document Celivarone plasma levels during the study.

Study identification

NCT ID
NCT00993382
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
486 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
Aug 31, 2009
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011
Last update posted
May 29, 2016

2009 – 2011

United States locations

U.S. sites
37
U.S. states
20
U.S. cities
36
Facility City State ZIP Site status
Investigational Site Number 840006 Huntsville Alabama 35801
Investigational Site Number 840042 Mobile Alabama 36608
Investigational Site Number 840014 Mesa Arizona 85206
Investigational Site Number 840032 Phoenix Arizona 85006
Investigational Site Number 840033 Tucson Arizona 85723
Investigational Site Number 840054 Redondo Beach California 90277
Investigational Site Number 840007 Redwood City California 94062
Investigational Site Number 840039 Colorado Springs Colorado 80909
Investigational Site Number 840002 Fort Myers Florida 33908
Investigational Site Number 840010 Orlando Florida 32806
Investigational Site Number 840005 Port Charlotte Florida 33952-8008
Investigational Site Number 840013 St. Petersburg Florida 33707
Investigational Site Number 840043 St. Petersburg Florida 33707
Investigational Site Number 840004 Augusta Georgia 30901
Investigational Site Number 840045 Chicago Illinois 60637
Investigational Site Number 840035 Lombard Illinois 60148
Investigational Site Number 840017 Kansas City Kansas 66160
Investigational Site Number 840022 Scarborough Maine 04074
Investigational Site Number 840009 Ann Arbor Michigan 48109-0759
Investigational Site Number 840026 Detroit Michigan 48236
Investigational Site Number 840003 Petoskey Michigan 49770
Investigational Site Number 840015 Ypsilanti Michigan 48197
Investigational Site Number 840049 Columbia Missouri 65201
Investigational Site Number 840019 Kansas City Missouri 64114
Investigational Site Number 840031 New York New York 10001
Investigational Site Number 840029 Tulsa Oklahoma 74104
Investigational Site Number 840037 Portland Oregon 97201-3098
Investigational Site Number 840024 Camp Hill Pennsylvania 17011
Investigational Site Number 840030 Doylestown Pennsylvania 18901
Investigational Site Number 840034 Upland Pennsylvania 19013
Investigational Site Number 840020 Charleston South Carolina 29406
Investigational Site Number 840048 Rapid City South Dakota 57701
Investigational Site Number 840011 Tullahoma Tennessee 37388
Investigational Site Number 840025 Chesapeake Virginia 23320
Investigational Site Number 840012 Norfolk Virginia 23507
Investigational Site Number 840038 Richmond Virginia 23225
Investigational Site Number 840016 Spokane Washington 99204

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 114 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00993382, 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 May 29, 2016 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00993382 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →