Pulmonary Hypertension Associated with Interstitial Lung Disease
Conditions
Brief summary
Change in 6MWD measured at peak exposure from Baseline to Week 24
Detailed description
Time from randomization to first clinical worsening over 24 weeks, Time from randomization to first major morbidity or mortality event over 24 weeks, Change in NT proBNP plasma concentration from Baseline over 24 weeks, Proportion of participants with improvement in NT proBNP levels over 24 weeks, Change in 6MWD measured at trough exposure from Baseline to Week 22, Change in 6MWD measured at peak exposure from Baseline over 20 weeks, Change in L-PF total symptom domain score from Baseline over 24 weeks, Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score Over 24 Week, Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Interventions
DRUG160 μg
DRUGor 320 μg or 640 µg )
Sponsors
Insmed Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 6MWD measured at peak exposure from Baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to first clinical worsening over 24 weeks, Time from randomization to first major morbidity or mortality event over 24 weeks, Change in NT proBNP plasma concentration from Baseline over 24 weeks, Proportion of participants with improvement in NT proBNP levels over 24 weeks, Change in 6MWD measured at trough exposure from Baseline to Week 22, Change in 6MWD measured at peak exposure from Baseline over 20 weeks, Change in L-PF total symptom domain score from Baseline over 24 weeks, Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score Over 24 Week, Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE) | — |
Countries
Austria, Denmark, France, Greece
Outcome results
None listed