ong-term safety study in patients included in CLARINET study with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt and for whom the shunt is still in place at one year of age - CLARINET LONG TERM

• Conditions: Patients at one year of age who are included in CLARINET, with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt, and for whom the shunt is still in place; MedDRA version: 9.1Level: HLGTClassification code 10010394Term: Congenital cardiac disorders

• Registration Number: EUCTR2008-004999-53-IT
• Lead Sponsor: Sanofi-Aventis recherche & de`veloppement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-15
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Patients randomized in the CLARINET study who still are receiving the study drug and with the palliative systemic-to-pulmonary artery shunt still in place at 1 year of age, - for whom the investigator?s decision is to continue the study drug treatment based on his/her judgment of the expected benefit/risk of continuing treatment with study drug and - for whom the parents/guardian have signed the informed consent to participate in this long-term safety study
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who have had a primary efficacy endpoint (shunt thrombosis or early cardiac related procedure of thrombotic nature) during the CLARINET study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the safety up to 18 months of age of the extended use of 0.2 mg/kg/day clopidogrel in patients who are included in CLARINET study with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt and for whom the shunt is still in place at one year of age;Secondary Objective: To assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.;Primary end point(s): The main endpoint will be safety evaluated by the incidence of adverse events and serious adverse events including bleeding