A PHASE 2A, OPEN-LABEL SINGLE ARM MULTICENTER EXPLORATORY STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF ORAL DOSES OF ROC-101 IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE (ILD-PH)

Condition studied

Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH)

Investigational medicinal product(s)

Eligibility

Primary endpoint

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], supplemental oxygen requirement, peripheral oxygen saturation [SpO2]), 12-lead electrocardiograms (ECG), and safety laboratory tests

Endpoint detail

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) and SV index (SVI), pulse pressure (PP), and pulmonary artery compliance (PAC) from Screening versus at 24 weeks