Status:
COMPLETED
Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Lead Sponsor:
Actelion
Conditions:
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Signed informed consent prior to any study-mandated procedure.
- Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.
- Women of childbearing potential must agree to use a reliable method of birth control.
- Key exclusion criteria:
- Known moderate or severe hepatic impairment (i.e. Child-Pugh C).
- Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.
- Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.
- Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.
- Any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's, Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic corticosteroids, Fluoxetine.
- Severe renal insufficiency (at randomization).
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02260557
Start Date
October 1 2014
End Date
June 1 2015
Last Update
February 3 2025
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