Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT04528056
Eligibility Criteria:
Inclusion Criteria:
1. Pulmonary artery systolic pressure estimated in the most recent echocardiography examination before screening ≧40mmHg.
2. Before the study, subjects received the best traditional pulmonary arterial hypertension(PAH) treatment (such as oral Ca2+ antagonists, oxygen therapy, digoxin, diuretics, and anticoagulants), and no increase, discontinuation, or dose change at least one month before randomization. But it is allowed to stop or adjust anticoagulants, and adjust the therapeutic dose of diuretics.
3. The results of echocardiography showed that the systolic and diastolic functions of the left ventricle were normal, and there was no clinically significant left heart disease (such as mitral valve disease).
Exclusion Criteria:
1. Patients who have received endothelin receptor antagonists and anti-inflammatory drugs within 30 days before randomization.
2. Patients with changes in the basic PAH treatment within one month before randomization (such as addition/removal of therapeutic drugs or dose adjustment; including but not limited to oxygen, diuretics, digoxin, anticoagulants, immunosuppressants, or Ca2+ antagonists ). But we allows the discontinuation of anticoagulants or change the dose and the change of diuretic dose.
3. Patients who diagnosed with other etiology of PAH, such as portal hypertension, pulmonary vein occlusive disease, etc.
4. Patients who have a history of left heart disease including ischemic heart disease, myocardial infarction, symptomatic coronary artery disease; or trans-channel radionuclide angiography, angiography, or echocardiography as assessed by mean pulmonary capillary wedge pressure (or left ventricular end diastolic volume) ≥ 15 mmHg or left ventricular ejection fraction ≤ 40%; or systemic hypertension that cannot be effectively controlled, systolic blood pressure\> 160 mmHg or diastolic blood pressure\> 100 mmHg.
5. Patients who have a history of lung diseases, including chronic obstructive pulmonary disease, interstitial lung disease, etc.
6. Patients who have a history of blood diseases, including a history of coagulation disorders within 6 months before screening.
7. Patients who are allergic to two or more drugs or food; or are known to be allergic to one anti-inflammatory drug (steroidal or non-steroidal anti-inflammatory drug).
8. Liver function test exceeds or equals 3 times the upper limit of normal or suffering from known Child-Pugh Class C liver disease.
9. Patients with chronic renal insufficiency, and the screening creatinine value is greater than 2.5mg/dL (221μmol/L) or need dialysis.
10. Patients with other diseases or conditions that can affect the results of the research.
11. Patients who participated in other study drugs or medical devices within 30 days before screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04528056
Study Brief:
Protocol Section:
NCT04528056