Pulmonary Arterial Hypertension
Conditions
Brief summary
Change in distance achieved on the six-minute walk test (6MWT) from baseline to Week 24
Detailed description
1.- 3. Time to first event of Clinical Worsening from first dose of Investigational Product (IP) through end of study 2. Proportion of subjects who achieve all of the components of a composite endpoint of clinical improvement at Week 24, in the absence of clinical worsening 3. Change in NT-proBNP from baseline to Week 24, 4.-5. 4. Proportion of subjects with ≥ 1 point decrease from baseline in REVEAL Lite 2 Risk Score at Week 24 5. Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs (SAEs), and treatment-emergent adverse events of special interest (AESIs)
Interventions
Sponsors
GB002 Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in distance achieved on the six-minute walk test (6MWT) from baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.- 3. Time to first event of Clinical Worsening from first dose of Investigational Product (IP) through end of study 2. Proportion of subjects who achieve all of the components of a composite endpoint of clinical improvement at Week 24, in the absence of clinical worsening 3. Change in NT-proBNP from baseline to Week 24, 4.-5. 4. Proportion of subjects with ≥ 1 point decrease from baseline in REVEAL Lite 2 Risk Score at Week 24 5. Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs (SAEs), and treatment-emergent adverse events of special interest (AESIs) | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed