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Simvastatin therapy in IBM - ND

Simvastatin therapy in IBM - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005942-35-IT
Enrollment
Unknown
Registered
2007-06-04
Start date
2007-03-14
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inclusion body myositis MedDRA version: 6.1 Level: PT Classification code 10028641

Interventions

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

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria: patient with severe form of IBM, with hight risk of developing muscolar toxicity

Design outcomes

Primary

MeasureTime frame
Main Objective: safety and tollerability of simvastatin;Secondary Objective: efficacy;Primary end point(s): functional index improvment—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026