Raynaud's Phenomenon secondary to Systemic Sclerosis MedDRA version: 18.0 Level: PT Classification code 10037912 Term: Raynaud's phenomenon System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: Selexipag
Product Code: ACT-293987
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Selexipag
Current Sponsor code: ACT-293987
Other descriptive name: SELEXIPAG
Concentration
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint is the average weekly number of RP attacks during maintenance period as determined from daily entries in electronic Diaries (eDiary).;Timepoint(s) of evaluation of this end point: NA;Main Objective: 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).;Secondary Objective: • to explore the effect of selexipag in reducing the impact of RP on subject's Quality of Life (QoL). • to assess the safety and tolerability of selexipag in subjects with RP secondary to SSc. • to explore relationships between plasma concentration of selexipag and its metabolite ACT-333679 to IP receptor activation or SSc biomarkers | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Germany, United Kingdom
Contacts
Public ContactGlobal Medical Information
Actelion Pharmaceuticals Ltd
Outcome results
None listed