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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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19 March 2012 |
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Main ID: |
EUCTR2006-005942-35-IT |
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Date of registration:
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04/06/2007 |
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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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Simvastatin therapy in IBM - ND
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Scientific title:
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Simvastatin therapy in IBM - ND |
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Date of first enrolment:
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14/03/2007 |
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Target sample size:
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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:2006-005942-35 |
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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: yes
Placebo: no
Other: no
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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:
IBM patient, males/females, age beetwen 18 and 75 years, patients able to give informed consent
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
patient with severe form of IBM, with hight risk of developing muscolar toxicity
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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inclusion body myositis
MedDRA version: 6.1
Level: PT
Classification code 10028641
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Intervention(s)
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Trade Name: SIVASTIN
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: FLEBOGAMMA 5%
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
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Primary Outcome(s)
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Main Objective: safety and tollerability of simvastatin
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Secondary Objective: efficacy
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Primary end point(s): functional index improvment
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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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