Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
Completed · Phase 3 · Has a placebo group
Conditions studied: Heart Defects, Congenital
In brief
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.
Key facts
- Study ID
- NCT00833703
- Run by
- Sanofi
- People needed
- 49
- Starts
- 2009-01-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2011-08-22
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients randomized in the CLARINET study,
- Still receiving the study drug,
- Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,
- Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug,
- Signed informed consent to participate in the long-term safety study.
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — São Paulo, Brazil
- Sanofi-Aventis Administrative Office — Paris, France
- Sanofi-Aventis Administrative Office — Berlin, Germany
- Sanofi-Aventis Administrative Office — Budapest, Hungary
- Sanofi-Aventis Administrative Office — Mumbai, India
- Sanofi-Aventis Administrative Office — Milan, Italy
- Sanofi-Aventis Administrative Office — Kuala Lumpur, Malaysia
- Sanofi-Aventis Administrative Office — México, Mexico
- Sanofi-Aventis Administrative Office — Warsaw, Poland
- Sanofi-Aventis Administrative Office — Porto Salvo, Portugal
- Sanofi-Aventis Administrative Office — Moscow, Russia
- Sanofi-Aventis Administrative Office — Barcelona, Spain
- Sanofi-Aventis Administrative Office — Taipei, Taiwan
- Sanofi-Aventis Administrative Office — Guildford Surrey, United Kingdom
Full record on ClinicalTrials.gov
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