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.
This study is a multi-center, randomized, placebo and positive controlled phase IIa proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute hemodynamic 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. During the screening period, the tube placement period, and the observation period, the patients will conduct various inspections and evaluation observations as required. The Swan-Ganz floating catheter and echocardiography were used to evaluate the efficacy of TPN171H; PK parameters: including Tmax, Cmax, AUC0-t , t1/2,CL/F, Vz/F, λz; Safety evaluation indicators include: vital signs, physical examination, laboratory examination (blood routine, blood biochemistry, blood gas analysis), 12-lead ECG, adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital CAMS&PUMC
Beijing, Beijing Municipality, China
Percentage of the maximum change in pulmonary vascular resistance(PVR) to the second baseline
Time frame: Within 24 hours after drug administration
Time of maximum change in PVR
Time frame: Within 24 hours after drug administration
The area under the curve for reduction in PVR
Time frame: Within 24 hours after drug administration
Change in arterial oxygenation
Time frame: Within 24 hours after drug administration
Change in right ventricular function
Time frame: Within 24 hours after drug administration
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The First Affiliated Hospital of Chongqing Medical University
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Gansu Provincial Hospital
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Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
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The Second Xiangya Hospital of Central South University
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First Affiliated Hospital Of Gannan Medical University
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Shanghai Pulmonary Hospital
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