At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Confirmed diagnosis of systemic sclerosis
- ✓Documented Raynaud's phenomenon (diagnosis or history)
- ✓At least 10 symptomatic Raynaud's attacks
- ✕Pregnancy or breastfeeding
- ✕Systolic blood pressure <85 mmHg
- ✕eGFR <30 mL/min/1.73 m2
- ✕Severe liver disease (Child-Pugh B or C) or ALT/AST >3× upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis
In Brief
A Phase 2 clinical trial evaluating Placebo IV infusion and Iloprost Injection, for intravenous use for Raynaud Phenomenon Secondary to Systemic Sclerosis. Completed, enrolled 34 participants across 16 sites.
Detailed Summary
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of Raynaud's Phenomenon attacks in subjects with symptomatic Raynaud's Phenomenon secondary to Systemic Sclerosis.
Study Details
Timeline
Interventions
Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.