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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-006035-32-IT
• Date of registration: 15/01/2008
• Prospective Registration: No
• Primary sponsor: AZIENDA OSPEDALIERA PISANA
• Public title: Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - ND
• Scientific title: Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - ND
• Date of first enrolment: 15/11/2007
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006035-32
• 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:
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.


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

Health Condition(s) or Problem(s) studied

Systemic Sclerosis and Hypercholesterolemia.
MedDRA version: 9.1 Level: LLT Classification code 10042953 Term: Systemic sclerosis

Intervention(s)

Trade Name: SINVACOR*28CPR RIV 20MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Secondary Objective: a) Assessment of serologic and/or plasmatic parameters of endothelial injury before and after 2 months of therapy; b) Tolerability assessment of statins in combination with symptomatic therapy for Systemic Sclerosis.

Primary end point(s): Improvement of endothelial function in terms of reversibility and/or stabilization of functional endothelial injury, in patients with Systemic Sclerosis and Hypercholesterolemia after 2 months of simvastatin treatment.

Main Objective: Assessment of endothelial function after statins treatment in combination with symptomatic therapy for Systemic Sclerosis.

Secondary ID(s)

2300/2007