Pulmonary Arterial Hypertension
Conditions
Brief summary
Change from Baseline in PVR at Week 16
Detailed description
Change from Baseline in 6MWT distance at Week 5, Week 10, and Week 16, Percent change from Baseline in 6MWT distance at Week 5, Week 10 and Week 16, Frequency of AEs and changes from Baseline in clinical laboratory evaluations, vital signs, ECG, and physical examination over the 16-week treatment period, Plasma PK parameters of TP and TRE, including Cmax, tmax, AUC24, AUC∞, AUClast, CL/F, Vd/F, and t½, on Day 1 and at Week 10, Change from Baseline in the concentration of NT-proBNP at Week 5, Week 10 and Week 16
Interventions
Sponsors
Insmed Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in PVR at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in 6MWT distance at Week 5, Week 10, and Week 16, Percent change from Baseline in 6MWT distance at Week 5, Week 10 and Week 16, Frequency of AEs and changes from Baseline in clinical laboratory evaluations, vital signs, ECG, and physical examination over the 16-week treatment period, Plasma PK parameters of TP and TRE, including Cmax, tmax, AUC24, AUC∞, AUClast, CL/F, Vd/F, and t½, on Day 1 and at Week 10, Change from Baseline in the concentration of NT-proBNP at Week 5, Week 10 and Week 16 | — |
Countries
Austria, Belgium, Denmark, Germany, Italy, Spain
Outcome results
None listed