Pulmonary Arterial Hypertension
Conditions
Brief summary
1. Part A: Change from baseline in PVR at Week 24, 2. Part B: Change from baseline in 6MWD at Week 24
Detailed description
1. Part A only: Change from baseline in 6MWD at Week 24, 2. Part B only: Change from baseline in PVR at Week 24, 3. Change from baseline in NT-proBNP concentrations at Week 24, 4. Time to all-cause death or the first occurrence of a clinical worsening event (time to clinical worsening), 5. Proportion of participants who improve from baseline in WHO FC or maintain WHO FC II from baseline to Week 24, 6. Proportion of participants who maintain low or intermediate-low risk score or achieve a lower ESC/ERS 4 strata risk score at Week 24, 7. Change from baseline in HRQoL / EmPHasis-10 total score at Week 24
Interventions
DRUGIkT-001Pro
DRUGPlacebo to match 100 mg IKT-001 tablets
Sponsors
Inhibikase Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Part A: Change from baseline in PVR at Week 24, 2. Part B: Change from baseline in 6MWD at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Part A only: Change from baseline in 6MWD at Week 24, 2. Part B only: Change from baseline in PVR at Week 24, 3. Change from baseline in NT-proBNP concentrations at Week 24, 4. Time to all-cause death or the first occurrence of a clinical worsening event (time to clinical worsening), 5. Proportion of participants who improve from baseline in WHO FC or maintain WHO FC II from baseline to Week 24, 6. Proportion of participants who maintain low or intermediate-low risk score or achieve a lower ESC/ERS 4 strata risk score at Week 24, 7. Change from baseline in HRQoL / EmPHasis-10 total score at Week 24 | — |
Outcome results
None listed