This is a multicenter, single-arm trial to evaluate the safety of the transition from Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10 clinical trial centers. The treatment phase of the study will last approximately 16 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Remodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.
Oral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.
Incidence of Adverse Events (AEs) through 16 Weeks
Time frame: 16 Weeks
Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16
Time frame: Baseline and Week 16
Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16
Time frame: Baseline and Week 16
Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16
Time frame: Baseline and Week 16
Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16
Time frame: Baseline and Week 16
Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16
Time frame: Baseline and Week 16
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