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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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8 June 2020 |
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Main ID: |
EUCTR2015-001065-76-FR |
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Date of registration:
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08/09/2015 |
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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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N/A
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Scientific title:
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N/A - ARCADE |
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Date of first enrolment:
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28/09/2015 |
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Target sample size:
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169 |
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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:2015-001065-76 |
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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: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 169
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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MedDRA version: 18.0
Level: PT
Classification code 10014316
Term: Ehlers-Danlos syndrome
System Organ Class: 10010331 - Congenital, familial and genetic disorders
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Intervention(s)
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Trade Name: IRBESARTAN
Product Name: IRBESARTAN
Pharmaceutical Form: Coated tablet
INN or Proposed INN: irbesartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective:
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Primary end point(s):
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Secondary Objective:
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 28/09/2015
Contact:
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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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