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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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
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.
Experimental: TPN171H 2.5mg group
TPN171H 2.5mg tablet + Placebo 10mg tablet
Experimental: TPN171H 5mg group
TPN171H 5mg tablet + Placebo 10mg tablet
Experimental: TPN171H 10mg group
TPN171H 10mg tablet + Placebo 5mg tablet
Placebo Comparator: Placebo group
Placebo 5mg tablet+ Placebo 10mg tablet
Active Comparator: tadalafil 20mg group
tadalafil tablet 20mg
Active Comparator: tadalafil 40mg group
tadalafil tablets 20mg *2
Drug: - TPN171H
Tablets; Oral; Single dose
Drug: - Placebo
Drug: - Tadalafil
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Peking Union Medical College Hospital
Beijing, Beijing, 100032
Peking University First Hospital
Beijing, Beijing, 100034
Not yet recruiting
Fuwai Hospital CAMS&PUMC
Beijing, Beijing, 100037
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, 400016
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Shanghai Pulmonary Hospital
Shanghai, Shanghai, 200433