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NCT00833703 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT00833703 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 49 participants.
The verdict
NCT00833703, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
This study is the extension of the CLARINET study \[NCT00396877 -EFC5314\] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt. The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age. The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.
Interventions
- DRUG placebo
- DRUG Clopidogrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00833703
The ClinicalTrials.gov registry entry for NCT00833703 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 49 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 2 interventions - of which placebo is the first listed.
NCT00833703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00833703 about?
NCT00833703 is a clinical study titled "Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation". This study is the extension of the CLARINET study \[NCT00396877 -EFC5314\] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt. The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 ...
What is the current status of trial NCT00833703?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2009-01. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00833703?
The interventions under investigation include: placebo (DRUG), Clopidogrel (DRUG).
Who is sponsoring clinical trial NCT00833703?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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