Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Selexipag

Criteria

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