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

Conditions: Patients affected by Systemic Sclerosis with Raynaud’s Phenomenon
MedDRA version: 9.1Level: LLTClassification code 10042953

Registration Number: EUCTR2010-019977-14-IT

Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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.