CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 906 enrolled
Drug / intervention
Clopidogrel (SR25990) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00396877
NCT00396877Phase 3Completed
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International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt

Sanofi·interventional·Posted Nov 8, 2006·Updated Oct 24, 2014

In Brief

A Phase 3 clinical trial evaluating Clopidogrel (SR25990) and placebo for Heart Defects, Congenital. Completed, enrolled 906 participants across 31 sites in 31 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Defects, Congenital
CountriesArgentina, Belgium, Brazil, Canada, China, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2006
Enrollment StartNov 1, 2006
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.7 years ago

Interventions

Clopidogrel (SR25990)drug

Form: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight

placebodrug

Form: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight