Estudio de seguridad a largo plazo en los pacientes incluidos en el estudio CLARINET con cardiopatía congénita cianosante paliada con derivación sistémica a la arteria pulmonar en los cuales persista la derivación al año de edad--------------------------------------------------------Long-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

sanofi-aventis recherche & développement0 个研究点目标入组 49 人开始时间: 2008年12月18日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•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

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

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