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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.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2006-005942-35-IT
Date of registration: 04/06/2007
Prospective Registration: Yes
Primary sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Public title: Simvastatin therapy in IBM - ND
Scientific title: Simvastatin therapy in IBM - ND
Date of first enrolment: 14/03/2007
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005942-35
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Italy
Contacts
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Email:
Affiliation: 
Name:    
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Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
inclusion body myositis
MedDRA version: 6.1 Level: PT Classification code 10028641
Intervention(s)

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-

Primary Outcome(s)
Main Objective: safety and tollerability of simvastatin
Primary end point(s): functional index improvment
Secondary Objective: efficacy
Secondary Outcome(s)
Secondary ID(s)
1413
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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