Peripheral Artery Disease
Conditions
Brief summary
This is a randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial
Detailed description
A randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial. The trial was divided into 4 dose groups: the positive drug Kaishi 10 μg group and the alprostadil liposome for injection 40μg, 80μg, 120μg group.
Interventions
40ug,once a day,continuous administration for 2 weeks
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 40 \<age ≤ 80 years ，regardless of gender; 2. Agree to participate in this clinical trial and sign the informed consent voluntarily; 3. Meet the diagnostic criteria of lower extremity arteriosclerosis obliteran (lower extremity ASO) (according to the definition of the 2015 Chinese lower extremity arteriosclerosis obliteran diagnosis and treatment guidelines), which are: age\> 40 years; have clinical manifestations of lower extremity arteriosclerosis obliteran ; Weakness or disappearance of distal arterial pulsation in ischemic limbs; 4. Ankle-brachial index (ABI) \<0.9; 5. Fontaine stage II or III. For subjects with Fontaine stage II, intermittent claudication distance is between 50m and 800m (fixed plate speed 3km / h, slope 12%); and at least 2 tests with difference of ≤25% (comparison based on the first measurement value, the second measurement is performed after the subject is fully rested the next day and after); 6. Imaging examinations such as color Doppler ultrasound, CTA, MRA, or DSA within 1 month before enrollment revealed lesions such as stenosis or occlusion of the corresponding lower limb arteries.
Exclusion criteria
1. Patients with pre-existing cardiac dysfunction, such as untreated heart failure, arrhythmia, coronary heart disease, mitral or aortic stenosis, or a history of myocardial infarction within the last 6 months; 2. Combining a history of stroke or cerebral hemorrhage, the judgment of researchers will affect the safety evaluation of efficacy; 3. Patients diagnosed or suspected of having pulmonary edema, pulmonary infiltration, or interstitial pneumonia through clinical or related examinations, or those with severe chronic obstructive ventilation disorder or respiratory insufficiency; 4. Obesity (BMI≥40); 5. Fontaine stage is IV, or patients with severe resting pain need to use strong analgesics or surgical amputation; 6. Hepatic impairment (ALT or AST ≥ 3 times ULN) or primary liver disease; 7. Renal dysfunction, SCr\> 1.5 times the upper limit of normal value; 8. Poorly controlled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg); 9. Diabetic patients with poor control (HbA1c\> 9%); 10. Patients with a history of interventional or bypass surgery or endovascular treatment in the past 3 months; or those who have stopped using prostaglandins for less than 5 half-life of the corresponding drugs; Elderly within 5 half-life of the corresponding drug (such as naphthylamine, pentoxifylline, butrodil, cilostazol, etc.); 11. Patients who have successfully received walking rehabilitation training in the past 6 months; 12. There are other diseases that significantly affect the walking distance, such as lower extremity joint disease, spinal disease, neuropathyt; 13. Patients with inflammatory vascular diseases, such as multiple arteritis, peripheral edema, thrombo-occlusive vasculitis, etc .; 14. Patients with total femoral or above, femoropopliteal artery occlusion, or above groin artery occlusion; 15. Patients with active peptic ulcer or bleeding tendency; 16. Glaucoma or hypertensive patients; 17. Patients who have used powerful analgesics (such as morphine) in the nearly a month; 18. Patients with mental illness or dementia; 19. Patients with malignant tumors; 20. Patients with previous allergies to similar products; 21. Those who have participated in drug clinical trials in the past 3 months; 22. Patients who are pregnant or nursing, or patients who are unable to perform effective contraception during the study period; 23. Active hepatitis B virus infection (HBV surface antigen positive and (HBVDNA quantification ≥1 × 103copies / mL), hepatitis C virus, syphilis antibody and HIV antibody positive; 24. Other patients considered by investigators to be unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intermittent claudication distance | After 2 weeks of treatment | Change of intermittent claudication distance from baseline after 2 weeks |
Countries
China
Contacts
Primary ContactGu Yong quan, doctor
Outcome results
None listed