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NCT00993382 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 486
- Enrollment target
NCT00993382: Completed Phase 2 study, sponsored by Sanofi.
NCT00993382 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 486 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (265% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00993382, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 486 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The presence of VT or VF was documented by ICD interrogation leading to any ICD interventions (shocks or anti-tachycardia pacing). The 10 first ICD interventions for each patient were centrally and blindly adjudicated by an Adjudication Committee.
Interventions
- DRUG Matching placebo
- DRUG Amiodarone
- DRUG Celivarone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00993382 record still lists
NCT00993382 is an interventional study that assigns participants to a tested intervention. The registered 486 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (265% higher).
The record links to 0 conditions, and to 3 interventions - of which Matching placebo is the first listed.
NCT00993382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00993382 about?
NCT00993382 is a clinical study titled "Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death". 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...
What is the current status of trial NCT00993382?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 486 participants. The study started on 2009-09. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00993382?
The interventions under investigation include: Matching placebo (DRUG), Amiodarone (DRUG), Celivarone (DRUG).
Who is sponsoring clinical trial NCT00993382?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00993382's enrollment target sits among peer trials
486 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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