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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 486 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00993382
The ClinicalTrials.gov registry entry for NCT00993382 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 486 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Matching placebo is the first listed.
NCT00993382 reports 0 study locations.
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.
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