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

AZIENDA OSPEDALIERA PISANA0 个研究点开始时间: 2008年1月15日最近更新: 2012年3月19日

试验速览

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•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

•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.

发起方

AZIENDA OSPEDALIERA PISANA