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A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).
Details
| Lead sponsor | Actelion |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 74 |
| Start date | 2014-10 |
| Completion | 2015-06 |
Conditions
- Raynaud's Phenomenon Secondary to Systemic Sclerosis
Interventions
- Selexipag
- Placebo
Primary outcomes
- Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period — From Day 26 to Day 56 ( +/- 7 days)
The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).