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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2010-019977-14-IT
• Date of registration: 27/12/2010
• Prospective Registration: No
• Primary sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA
• Public title: Efficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - ND
• Scientific title: Efficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - ND
• Date of first enrolment: 04/11/2010
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019977-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Italy

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Trade Name: PLETAL
Pharmaceutical Form: Tablet
INN or Proposed INN: CILOSTAZOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: - Evaluate pre- and post-therapy modifications through the evaluation of the FMD (flow-mediated dilation) of the brachial artery
- Evaluate in vitro variations of the immunological status (regulatory lymphocytes, effector lymphocytes, pro- and anti-inflammatory cytokines) using immunochemical techniques and flux cytometry

Main Objective: Evaluate the efficacy of Cilostazol in reducing the frequency and severity of Raynaud’s Phenomenon attacks in patients affected by Systemic Sclerosis

Primary end point(s): Evaluate the efficacy of Cilostazol in reducing the frequency and severity of Raynaud’s Phenomenon attacks in patients affected by Systemic Sclerosis

Secondary ID(s)

CILOS-RAY2010