drugset / Trial / NCT04483115
Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension
Phase 2
Completed
60 enrolled
Vigonvita Life Sciences
Shanghai Institute of Materia Medica, Chinese Academy of Sciences · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a phase IIa proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute haemodynamic parameters in patients with pulmonary arterial hypertension.The trial is expected to include 60 patients, divided into 6 groups, according to 1:1:1:1:1:1 into the placebo group and the test drugs 2.5mg, 5mg, 10mg group, tadalafil tablets 20mg, 40mg group, each group 10 cases.
Timeline
- Start
- 2020-11-16
- Primary completion
- 2022-06-29
- Completion
- 2022-06-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TPN171H | Unknown | 2.5 mg | Oral |
| Subject | TPN171H | Unknown | 5 mg | Oral |
| Subject | TPN171H | Unknown | 10 mg | Oral |
| Comparator | Tadalafil | Small molecule | 20 mg | Oral |
| Comparator | Tadalafil | Small molecule | 40 mg | Oral |