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: LLTClassification code 10019273Term: Heart disease congenital

• Registration Number: EUCTR2008-004999-53-HU
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-10
• 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