Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - ND

• Conditions: Systemic Sclerosis and Hypercholesterolemia.; MedDRA version: 9.1Level: LLTClassification code 10042953Term: Systemic sclerosis

• Registration Number: EUCTR2007-006035-32-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified