Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud
Phase 1
- Conditions
- Raynaud syndrome with / without systemic sclerosis
- Registration Number
- EUCTR2006-000905-41-AT
- Lead Sponsor
- ao. Univ. Prof. Dr. Elisabeth Aberer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with Raynaud syndrome with / without scleroderma, Iloprost treatment since >1 month
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
Abnormal hemostasis, diabetes, pregnancy, breast feeding, coronary heart disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the action of Iloprost on the number, severity and duration of Raynaud attacks in comparison to placebo in patients with Raynaud syndrome with / without scleroderma. ;Secondary Objective: Measuring skin temperature before and after infusion of iloprost or placebo.;Primary end point(s): Number, duration and severity of Raynaud attacks after treatment with Iloprost or placebo for 5 months.
- Secondary Outcome Measures
Name Time Method