Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH)
Conditions
Brief summary
1. Change in PVR from Baseline versus at 24 weeks, 2. Safety assessments, including adverse events (AEs), vital signs (body temperature, heart rate [HR] and blood pressure [BP], respiratory rate [RR], fraction of inspired oxygen [FiO2] and saturation of peripheral oxygen [SpO2]), 12-lead electrocardiograms (ECG) and safety laboratory tests
Detailed description
1. Change in 6MWD from Baseline versus at 24 weeks, 2. Change in NT-proBNP from Baseline versus at 24 weeks, 3. Change in WHO FC from Baseline versus at 24 weeks, 4. Change in right atrial pressure (RAP), mean pulmonary artery pressure (mPAP), cardiac output (CO), cardiac index (CI), pulmonary capillary wedge pressure (PCWP), mixed venous oxygen saturation (SvO2), stroke volume (SV) SV index (SVI), pulse pressure (PP), and pulmonary artery compliance (PAC) from Screening versus at 24 weeks
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in PVR from Baseline versus at 24 weeks, 2. Safety assessments, including adverse events (AEs), vital signs (body temperature, heart rate [HR] and blood pressure [BP], respiratory rate [RR], fraction of inspired oxygen [FiO2] and saturation of peripheral oxygen [SpO2]), 12-lead electrocardiograms (ECG) and safety laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in 6MWD from Baseline versus at 24 weeks, 2. Change in NT-proBNP from Baseline versus at 24 weeks, 3. Change in WHO FC from Baseline versus at 24 weeks, 4. Change in right atrial pressure (RAP), mean pulmonary artery pressure (mPAP), cardiac output (CO), cardiac index (CI), pulmonary capillary wedge pressure (PCWP), mixed venous oxygen saturation (SvO2), stroke volume (SV) SV index (SVI), pulse pressure (PP), and pulmonary artery compliance (PAC) from Screening versus at 24 weeks | — |
Countries
France, Germany, Italy, Latvia, Poland, Spain