E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neonates or infants (age less than or equal to 92 days at the time of randomization) with systemic to pulmonary arterial shunt for palliation of cyanotic congenital heart disease. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019273 |
E.1.2 | Term | Heart disease congenital |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of 0.2 mg/kg/day of clopidogrel versus placebo for the reduction of all-cause mortality and shunt-related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety of clopidogrel in the study population. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Sub-study n°1 Full title : Pharmacokinetic Substudy Date : 2006/08/11 Version : 2.0 Sub-study n°1 objectives : The description of SR26334 plasma concentrations in the targeted population and the possible relationship with covariates such as age, weight, and gender.
Sub-study n°2 Full title : Pharmacodynamic Substudy Date : 2006/08/11 Version : 2.0 Sub-study n°2 objectives : The description of the platelet aggregation inhibition in this population. |
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E.3 | Principal inclusion criteria |
- Neonate or infant (age less than or equal to 92 days at the time of randomization) with cyanotic congenital heart disease. - Treated by any palliative systemic-to-pulmonary artery shunt (closed shunt or open shunt, Norwood, Sano, stent of ductus arteriosus). - Signed informed consent obtained from patient’s legally acceptable representative (parents or guardians). |
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E.4 | Principal exclusion criteria |
- Active bleeding or increased risk of bleeding (bleeding disorders [e.g., hemophilia, von Willebrand disease], artero-venous malformations, aneurysms) or previous intracranial (Grades II-IV) or life-threatening hemorrhage. - Allergy to 2 or more classes of drug. - Current treatment with thienopyridine (open label clopidogrel or ticlopidine), dipyridamole or oral anticoagulant. - Adjusted gestational age less than 34 weeks. - Unable to receive study drug orally or enterically. - Concurrent use of another experimental drug/device or participation in another investigational drug or device trial within the last 30 days, except if the study involves an FDA approved drug/device. - Current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure (i.e., more than 2.5 times the upper limit for age of hepatic enzymes or creatinine).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy criterion is the first occurrence of any component of the primary composite endpoint of: -Any death or -Shunt thrombosis requiring intervention or -Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered of thrombotic nature |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 54 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |