Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Phase 2
Completed
- Conditions
- Raynaud's Phenomenon Secondary to Systemic Sclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT02260557
- Lead Sponsor
- Actelion
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo matching selexipag tablets is administered according to the same schedule as selexipag Selexipag Selexipag Selexipag is initiated at 200 µg twice daily (b.i.d.) and up-titrated every 3 days in 200 μg b.i.d. increments up to the maximum tolerated dose (MTD) for each individual patient but not above 1600 µg during the 3-week titration phase. This is followed by a 5-week maintenance phase, during which patients continue the treatment at their individual MTD.
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Number of patients with treatment-emergent adverse events Up to end of study (Day 86 +/- 7 days) A treatment-emergent adverse event is any adverse event (AE) temporally associated with the use of a study treatment, whether or not considered related to the study treatment, including any abnormalities in ECG parameters, vital signs or laboratory tests
Number of patients with treatment-emergent serious adverse events Up to end of study (Day 86 +/- 7 days)
Trial Locations
- Locations (1)
Investigator Site
🇬🇧Salford, United Kingdom