EUCTR2007-006035-32-IT
Active, not recruiting
Not Applicable
Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - ND
AZIENDA OSPEDALIERA PISANA0 sitesJanuary 15, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AZIENDA OSPEDALIERA PISANA
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Male and female patients with diagnosis of Systemic Sclerosis supported by ACR preliminary criteria of 1980; b) 18 years \< age \< 70 years; c) Limited cutaneous systemic sclerosis; d) Hypercholesterolemia (LDL cholesterol \> 130 mg/dl and total cholesterol \> 200 mg /dl); e) Statins wash out at least 6 months before the beginning of the treatment; f) Concomitant therapy for Systemic Sclerosis with antithrombotics (Iloprost in cycles), cortisones (Prednisone \< 8 mg); Ca\-antagonists; allowed immunosuppressants; g) Acceptance of protocol and written 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
- •a) Patients over age 70 years; b) Pregnancy; c) Breast\-feeding; d)Hypersensibility to simvastatin or any other substance from the list of excipients; e) Sclerodermic renal crisis in 3 months before the study; f) Active hepatopathy or persistent increase of serum transaminases without a clear cause; g) Clinical and hematochemical evidence of polimyosite; h) Hypothyroidism; i)Therapy with: cyclosporine, antifungine azoles (Itraconazole, Ketoconazole), protease inhibitors for HIV, Erithromycin, Clarithromycin, Telithromycin and Nefazodone, oral anticoagulants, Digitalis, fibrates and niacine, benzodiazepines, antibiotic macrolides; l)Insufficient compliance of patient.
Outcomes
Primary Outcomes
Not specified
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