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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period
The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).
Time frame: From Day 26 to Day 56 ( +/- 7 days)
Number of patients with treatment-emergent adverse events
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
Time frame: Up to end of study (Day 86 +/- 7 days)
Number of patients with treatment-emergent serious adverse events
Time frame: Up to end of study (Day 86 +/- 7 days)
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