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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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12 November 2012 |
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Main ID: |
EUCTR2006-005230-20-IT |
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Date of registration:
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12/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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EX VIVO EFFECT OF AMINAFTONE (CAPILLAREMA) ON THE ENDOTELIAL FUNCTION IN SYSTEMIC SCLEROSIS.
Effetto ex vivo dell’aminaftone (Capillarema) sulla funzione endoteliale nella Sclerosi Sistemica
- ND
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Scientific title:
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EX VIVO EFFECT OF AMINAFTONE (CAPILLAREMA) ON THE ENDOTELIAL FUNCTION IN SYSTEMIC SCLEROSIS.
Effetto ex vivo dell’aminaftone (Capillarema) sulla funzione endoteliale nella Sclerosi Sistemica
- ND |
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Date of first enrolment:
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14/07/2006 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005230-20 |
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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: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Soggetti affetti da SSc, indipendentemente dalla variante di malattia (forma cutanea limitata o diffusa)
Terapia stabile da almeno tre mesi
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Deficit di Glucosio-6-Fosfato-Deidrogenasi (fauvismo)
Asma
Donne in gravidanza
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Variazione della gravita' del fenomeno di Raynaud misurata mediante diario dei sintomi e scala analogica visiva VAS ? Visual Analogic Scale (6).
Variazione dello stato globale di malattia valutata mediante HAQ ? Health Assessment Questionnaire (7).
MedDRA version: 9.1
Level: LLT
Classification code 10042953
Term: Systemic sclerosis
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Intervention(s)
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Trade Name: CAPILLAREMA
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
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Primary Outcome(s)
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Main Objective: Funzione endoteliale
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Primary end point(s): Variazione nei livelli plasmatici dei marcatori di danno endoteliale (citochine IL-1 e IL-6, molecole d'adesione ICAM-1 e VCAM-1)
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Secondary Objective: Gravita' del fenomeno di Raynaud
Stato globale di malattia
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Secondary ID(s)
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NOT AVAILABLE
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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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