A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis

• Conditions: Raynaud's Phenomenon secondary to Systemic Sclerosis; MedDRA version: 18.0Level: PTClassification code 10037912Term: Raynaud's phenomenonSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-000865-34-GB
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-10
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

At Screening visit:
• Signed informed consent prior to any study-mandated procedure.
• Male and female subjects aged 18 years and above with history of
recurrent multiple weekly RP attacks secondary to SSc.
• A woman of childbearing potential is eligible only if the following
applies:
-Negative urine pregnancy test at screening visit.
-Agreement to undertake monthly pregnancy tests during the
study and up to 30 days after study treatment discontinuation.
-Agreement to use one reliable method of birth control

At randomization visit all the above apply and:
• Subjects with RP who have experienced at least 7 RP attacks in the 7 days prior to the randomization visit (i.e., baseline week) with attacks on at least 5 different days.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

At screening visit:
• Known 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 or are scheduled to receive any of
those treatments during the intended study period.
• Subjects who have received a Phosphodiesterase type 5 (PDE-5)
inhibitor within 1 week prior to the screening visit or are scheduled
to receive any such treatment during the intended study period.
• Any dose change or initiation of any of the following drugs within 1
month prior to the screening visit:
oCalcium channel blockers
oNitrates or nitric oxide donors
oERA's
oAlpha-blockers
oAntithrombotic agents
oNSAIDs (occasional use allowed)
oAngiotensin Converting Enzyme (ACE) inhibitors
oBeta-blockers
oClonidine
oSystemic corticosteroids
oFluoxetine

At randomization visit all the above apply and:
• Severe renal insufficiency: estimated creatinine clearance <30
mL/min/1.73 m² or serum creatinine >2.5 mg/dL (221 µmol/L)
based on central laboratory results from screening visit blood sample
• Subjects who were not compliant with run-in procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified