Efficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - ND

AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA0 个研究点开始时间: 2010年12月27日最近更新: 2012年3月19日

试验速览

暂无简介。

•- Patients suffering from Raynaud’s Phenomenon (mild to severe) and no counter indications for Cilostazol therapy
•- The study will be conducted on patients affected by Systemic Sclerosis followed in the ambulatory of Immunology of the Department of Internal Medicine - American College of Rheumatology criteria is applied for the diagnosis of Systemic Sclerosis, disease classification (Limited or Diffuse) is determined following LeRoy’s criteria. Disease activity will be evaluated by the EUSTAR Systemic Sclerosis Activity score
•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

•- Severe renal failure: ClCr < 25 ml/min. - Mild to severe hepatic failure. - Congestive heart failure. - Pregnancy and lactation. - Patients with hemorrhagic predisposition (e.g. peptic ulcer, hemorrhagic stroke in the last 3 months, surgical procedures in the last 6 months, diabetic proliferative retinopathy, arterial hypertension not controlled) - Patients assuming CYP3A4 or CYP2C19 inhibitors (e.g. cimetidine, diltiazem, eritromicin, ketoconazole, lansoprazole, omeprazole, HIV-1 protease inhibitors) - Patients with history of ventricular tachycardia, ventricular fibrillation, multifocal ventricular extrasistolia and long QT syndrome.

发起方

AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA