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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006035-32-IT
Enrollment
Unknown
Registered
2008-01-15
Start date
2007-11-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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-

Sponsors

AZIENDA OSPEDALIERA PISANA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) Male and female patients with diagnosis of Systemic Sclerosis supported by ACR preliminary criteria of 1980; b) 18 years 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026