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Clinical Trials/EUCTR2008-004999-53-ES
EUCTR2008-004999-53-ES
Active, not recruiting
Phase 1

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 sites49 target enrollmentDecember 18, 2008
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Conditionspacientes 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------------------------------------------------------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: 8.1Level: LLTClassification code 10019273Term: Heart disease congenital
DrugsPLAVIX 75 mg comprimidos con cubierta pelicular

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
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------------------------------------------------------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.
Sponsor
sanofi-aventis recherche & développement
Enrollment
49
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 18, 2008
End Date
July 21, 2010
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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