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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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24 July 2012 |
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Main ID: |
EUCTR2008-004999-53-HU |
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Date of registration:
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10/11/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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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 |
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Date of first enrolment:
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18/12/2008 |
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Target sample size:
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32 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004999-53 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Belgium
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France
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Germany
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Hungary
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Italy
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Portugal
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Spain
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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: 9.1
Level: LLT
Classification code 10019273
Term: Heart disease congenital
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Intervention(s)
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Trade Name: Plavix
Pharmaceutical Form: Powder and solvent for oral solution
INN or Proposed INN: clopidogrel hydrogen sulfate
CAS Number: 120202-66-6
Current Sponsor code: SR25990C
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Powder and solvent for oral solution
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): The main endpoint will be safety evaluated by the incidence of adverse events and serious adverse events including bleeding.
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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.
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Secondary Objective: To assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.
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Secondary ID(s)
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2008-004999-53-PT
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LTS10916
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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