The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
344
Oral inhalation using a capsule-based dry powder inhaler device.
Oral inhalation using a capsule-based dry powder inhaler device.
Change in 6-Minute Walk Distance (6MWD) Measured at 1 to 3 Hours Post-Dose From Baseline at Week 24
Time frame: Baseline, Week 24
Percentage of Participants With an Improvement From Baseline in World Health Organization (WHO) Functional Class at Week 24
Time frame: Baseline, Week 24
Change in 6MWD Measured at 24 Hours (±2) Since the Last Dose From Baseline at Week 22
Time frame: Baseline, Week 22
Change From Baseline in the Concentration of N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) at Week 24
Time frame: Baseline, Week 24
Change From Baseline at Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire (PAH-SYMPACT) Physical Impacts Domain Score
Time frame: Baseline, Week 24
Change From Baseline at Week 24 in PAH-SYMPACT Cardiopulmonary Symptoms Domain Score
Time frame: Baseline, Week 24
Time to First Clinical Worsening Event From Baseline Through Week 24
Time frame: Baseline up to Week 24
Change in Multiparameter Risk Score From Baseline at the Scheduled Visits Over 24 Weeks (REVEAL Lite 2.0)
Time frame: Baseline up to Week 24
Changes From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) per Right Ventricular Systolic Pressure (RVSP) at Week 24
Time frame: Baseline, Week 24
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Change From Baseline at the Scheduled Visits Over 24 Weeks in PAH-SYMPACT Cardiovascular Symptoms Domain Score
Time frame: Baseline up to Week 24
Changes From Baseline at the Scheduled Visits Over 24 Weeks in PAH-SYMPACT Cognitive/Emotional Impacts Domain Score
Time frame: Baseline up to Week 24
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time frame: Pre-dose and post-dose at multiple timepoints up to Week 24