Status:
COMPLETED
Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Heart Defects, Congenital
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 prima...
Detailed Description
Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00833703
Start Date
January 1 2009
End Date
July 1 2010
Last Update
August 22 2011
Active Locations (15)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
São Paulo, Brazil
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Berlin, Germany