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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:  EUCTR2007-004359-12-IT
Date of registration: 21/11/2007
Prospective Registration: Yes
Public title: Simvastatin treatment in inclusion body myositis (IBM) - ND
Scientific title: Simvastatin treatment in inclusion body myositis (IBM) - ND
Date of first enrolment: 05/04/2007
Target sample size:
Recruitment status: Not Recruiting
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  
Countries of recruitment
Key inclusion & exclusion criteria
Inclusion criteria:
Patients affected by inclusion body myositis (diagnosis based on clinical, radiological and pathological data); males and females; aged between 18 and 80 years; patients able to give an informed consensus
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:
Patients affected by a severe form of inclusion body myositis (disease duration > 10 years, severe dysphagia requiring an invasive nutritional support) or already treated with immunosuppressive drugs; patients in whom IVIG administration is not indicated (IgA deficiency, renal insufficiency, etc.); patients at high risk to develop rhabdomyolysis (patients with severe systemic diseases such as hepatopathies or thyroid dysfunction, patients in treatment with drugs that increase the risk of muscle toxicity, patients with CK basal levels five times higher than normal value); fertile women who intend to be pregnant or they are already pregnant.

Age minimum:
Age maximum:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
MedDRA version: 6.1 Level: PT Classification code 10028289

Trade Name: SIVASTIN
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)
Main Objective: Evaluation of safety and tolerability of simvastatin, administered orally to patients with IBM
Primary end point(s): Improvement of functional indexes (IMACS definition: increase of at least 20% in three of core set measures; worsening of maximum 25% in no more than two core set measures is accepted, excluding the manual evaluation of muscle strength)
Secondary Objective: Evaluation of clinical efficacy of simvastatin, administered orally to patients with IBM
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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