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NCT00396877 · ClinicalTrials.gov registry record · Phase 3
Efficacy And 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
- 906
- Enrollment target
NCT00396877 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 906 participants.
The verdict
NCT00396877, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 906 participants
- Enrollment target
Study Summary
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important. The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt \[BTS\]). The secondary objective was to assess the safety of Clopidogrel in the study population.
Interventions
- DRUG placebo
- DRUG Clopidogrel (SR25990)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 906 participants |
| Start Date | 2006-11 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00396877
The ClinicalTrials.gov registry entry for NCT00396877 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 906 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.
NCT00396877 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00396877 about?
NCT00396877 is a clinical study titled "Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation". Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important. The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the re...
What is the current status of trial NCT00396877?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 906 participants. The study started on 2006-11. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00396877?
The interventions under investigation include: placebo (DRUG), Clopidogrel (SR25990) (DRUG).
Who is sponsoring clinical trial NCT00396877?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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