Drug and toxin-induced PAH, Heritable PAH, HIV infection, or congenital heart disease, PAH associated with connective tissue disease, Pulmonary arterial hypertension (PAH) in one of the following groups: Idiopathic PAH
Conditions
Brief summary
Phase 2 Cohort: Change from Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks, Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
Detailed description
Phase 2 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks, Phase 2 Cohort: Change from Baseline in Mean Right Arterial Pressure (mRAP) at 12 Weeks, Phase 2 Cohort: Change from Baseline in Cardiac Index (CI) at 12 weeks, Phase 2 Cohort: Change from Baseline in Stroke Volume Index (SVI) at 12 weeks, Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks, Phase 3 Cohort: Change from Baseline in World Health Organization Functional Class (WHO-FC) at 12 Weeks, Phase 2 and 3 Cohorts: Number of Participants Who Experience an Adverse Event, Phase 2 and 3 Cohorts: Number of Participants Who Discontinue Study Drug Due to an Adverse Event
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2 Cohort: Change from Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks, Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks, Phase 2 Cohort: Change from Baseline in Mean Right Arterial Pressure (mRAP) at 12 Weeks, Phase 2 Cohort: Change from Baseline in Cardiac Index (CI) at 12 weeks, Phase 2 Cohort: Change from Baseline in Stroke Volume Index (SVI) at 12 weeks, Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks, Phase 3 Cohort: Change from Baseline in World Health Organization Functional Class (WHO-FC) at 12 Weeks, Phase 2 and 3 Cohorts: Number of Participants Who Experience an Adverse Event, Phase 2 and 3 Cohorts: Number of Participants Who Discontinue Study Drug Due to an Adverse Event | — |
Countries
Belgium, France, Germany, Greece, Italy, Poland, Sweden