Pulmonary Hypertension associated with interstitial lung disease (WHO Group 3)
Conditions
Brief summary
Change from Baseline to Week 16 in 6-minute walk distance (6MWD)
Detailed description
Time to first occurrence of 1 of the following clinical worsening event (CWE) criterion are met: -Death (all causes) -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study, at 2 consecutive visits and at least 1 week apart, Change from Baseline to Week 24 in 6-Minute Walk Distance (6MWD), Change from Baseline to Week 16 in 6MWD
Interventions
DRUGTreprostinil Liposome
DRUGL606 Placebo Inhalation Suspension
Sponsors
Liquidia Technologies Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 16 in 6-minute walk distance (6MWD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of 1 of the following clinical worsening event (CWE) criterion are met: -Death (all causes) -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study, at 2 consecutive visits and at least 1 week apart, Change from Baseline to Week 24 in 6-Minute Walk Distance (6MWD), Change from Baseline to Week 16 in 6MWD | — |
Outcome results
None listed