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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: Completed Phase 3 study, sponsored by Sanofi.
NCT00396877 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 906 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee. Only the first event was counted.
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 |
What the finished NCT00396877 record still lists
NCT00396877 is an interventional study that assigns participants to a tested intervention. The registered 906 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00396877 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00396877's enrollment target sits among peer trials
906 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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