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.
USA012
Los Angeles, California, United States
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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USA008
Santa Barbara, California, United States
RECRUITINGUSA005
Torrance, California, United States
RECRUITINGUSA010
Kansas City, Kansas, United States
RECRUITINGUSA028
Omaha, Nebraska, United States
RECRUITINGUSA013
Rochester, New York, United States
RECRUITINGUSA006
Philadelphia, Pennsylvania, United States
RECRUITINGUSA007
Anderson, South Carolina, United States
RECRUITINGARG001
Buenos Aires, Buenos Aires F.D., Argentina
RECRUITINGARG004
Río Cuarto, Córdoba Province, Argentina
RECRUITING...and 16 more locations
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