pulmonary arterial hypertension
Conditions
Interventions
One capsule of ST10 30 mg or placebo 30 mg is taken orally twice a day, and the capsule should be taken with an appropriate amount of water if possible.
Sponsors
Kobayashi Yuichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with PAH who meet any of the following criteria of the Guidelines for Pulmonary Thromboembolism, Deep Venous Thrombosis, and Pulmonary Hypertension (2025 Revised Edition) 1) Idiopathic pulmonary arterial hypertension (IPAH) 2) Hereditary pulmonary arterial hypertension (HPAH) 3) Drug- or poison-induced pulmonary arterial hypertension (DPAH) 4) PAH associated with the following diseases (a) Connective-tissue disease (b) Simple congenital systemic circulation-pulmonary circulation shunt (however, more than 1 year must have elapsed after surgical operation) - Patients with PAH who meet any of the following criteria 1) Patients who have a history of taking one or more oral iron preparations and who had an inadequate response or did not tolerate the iron preparations 2) Patients for whom administration of any oral iron preparations is considered inappropriate - Patients with the following hemoglobin (Hb) levels when measured during screening: 1) Females: Hb >= 8.0 g/dL and Hb = 8.0 g/dL and Hb = 50 m and < 440 m - Patients with stable PAH symptoms
Exclusion criteria
Exclusion criteria: - Patients with anemia of causes other than iron deficiency - Patients with comorbidities with significant active bleeding that may contribute to the onset or persistence of anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in six-minute walk distance (6MWD) after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in WHO functional class after 12 weeks of treatment - Change from baseline in NT-proBNP levels after 12 weeks of treatment - Changes from baseline in pulmonary hemodynamics at rest after 12 weeks of treatment - Changes from baseline in echocardiography at 12 weeks after treatment | — |
Contacts
Public ContactYuichi Kobayashi
Medleap Pharma Co. Ltd.
Outcome results
None listed