Pulmonary arterial hypertension
Conditions
Interventions
Experimental group 1:18mg MN-08 tablets
Experimental group 2:36mg MN-08 tablets
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 75 years; 2. Diagnosed with pulmonary arterial hypertension (PAH), including: (1) Idiopathic PAH (IPAH); (2) Associated with any of the following: 1) Connective tissue diseases; 2) Congenital heart disease with simple systemic - pulmonary bypass at least one year after surgical repair. 3. WHO heart functional class II-III; 4. Right heart catheterization (RHC) was performed at the time of screening or prior to screening and was consistent with the PAH diagnosis, complying with all the following criteria: (1) Mean pulmonary arterial pressure at rest (mPAP) >= 25 mmHg; (2)Pulmonary capillary wedge pressure (PCWP) 3.00 Wood unit or > 240 dynes/sec/cm^-5. 5. Two consecutive 6-minute walk distance (6MWD) test results should be 150~450 meters (including upper and lower limits) and the test should conduct on different study days during the screening period. The second test result should be within the range of ±15% of the first test. If both tests are performed on the same day, the time interval must be >4 hours; 6. Lung function tests (LFTs) were performed during the screening period or prior to screening, with total lung volume (TLC) >= 60% predicted value, forced expiratory volume in one second/forced vital capacity (FEV1/FVC)>= 50%; 7. Subjects willing to take effective contraceptive measures within 6 months after signing the informed consent form; 8. Subjects himself or his legal guardian agree to participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with a definite diagnosis of other types of pulmonary arterial hypertension; 2. PAH induced by connective tissue disease with abnormal inflammatory markers (WBC, ESR, CRP, and PCT) at screening; 3. A history of ischemic heart disease within the previous 6 months, or left myocardial disease (PAWP, left ventricular end-diastolic pressure > 15 mmHg, or left ventricular ejection fraction LVEF < 40%); 4. Inability to perform 6 minutes walking distance test due to disability, injury, or the need to use therapeutic equipment at the bedside; 5. Subjects who cannot discontinue phosphodiesterase type 5 (PDE5) inhibitors, guanylate cyclase agonists, nitrates, or other NO donor agents within 7 days prior to initial administration; 6. Resting heart rate over 120 beats/min, systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 100 mmHg after drug control, or hypotension (resting systolic blood pressure and/or diastolic blood pressure below the lower limit of normal value), bradycardia (resting heart rate below 60 beats/min); 7. Diagnosed with moderate to severe sleep apnea syndrome; 8. Positive test for treponema pallidum (TP) or HIV by etiological examination; 9. ALT, AST, serum creatinine more than 3 times the upper limit of normal value, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis; 10. Subjects with advanced renal disease (undergoing hemodialysis, peritoneal dialysis, or kidney transplantation); 11. Any history of allergic constitution and allergy to memantine or any excipient in the formulation of the drug used in this study; 12. Enrolled in other drug trials within 4 weeks prior to initial administration or still in the 5 half-life of the drug; 13. Blood pregnancy test positive women, lactating women, male and female patients trying to have children during the test; 14. Previous or current history of drug dependence or any psychiatric illness; 15. Patients with cerebrovascular events (such as transient ischemic attack and cerebral infarction) within 3 months before the first drug administration; Or subjects with right heart failure within 3 months prior to first dosing (NYHA class IV); 16. Other conditions that researchers deemed inappropriate for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute hemodynamics of a single dose;Multiple dosing randomized double-blind placebo-controlled parallel study; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute hemodynamics of a single dose;Heart rate;Cardiac index;Cardiac output;Mean pulmonary arterial pressure;Systolic pressure;Diastolic blood pressure;Mixed venous oxygen saturation;6 minutes walking distance;Brain natriuretic peptide;Partial pressure of oxygen in arterial blood;Partial pressure of carbon dioxide in arterial blood;Saturation of arterial blood oxygen;Heart functional classification;Dyspnea scale scores;emPHasis-10 health-related quality of life scores;Multiple dosing randomized double-blind placebo-controlled parallel study; | — |
Countries
China
Contacts
Public ContactZhong Nanshan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed