Status:
COMPLETED
"Unifuzol®" in Patients With Peripheral Arterial Disease
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-79 years
Phase:
PHASE2
Brief Summary
The present study is a multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of the drug Unifuzol® (L-arginine) in patients with obliterating atherosclerosis of th...
Eligibility Criteria
Inclusion
- Signed Informed Consent
- Male and female patients 40-79 years old
- Patients with atherosclerosis of native arteries of the lower extremity vessels (ICD-10 code: I70.2)
- Clinical syndrome of chronic lower limb ischemia
- The symptom of intermittent claudication persisting for 6 months or more (before the start of screening), causing a stable restriction of physical activity to the maximum walking distance 100-299 m
- The ankle-brachial index (ABI) less than 0.9; in patients with diabetes mellitus ABI \>1.2 is acceptable, provided the occlusion of the main arteries of the lower extremities is confirmed
- Patient consent to the use of adequate methods of contraception or full abstinence from sexual activity for the period of the study and within 30 days after its completion
- The difference between the maximum walking distance at the second and the first treadmill test at the screening (interval at least 3 days) does not exceed 25% from baseline, i.e. the first treadmill test
- Patients not receiving drugs for the treatment of atherosclerosis obliterans of the lower extremities or receiving them in constant doses for at least 6 weeks prior to screening.
- No contraindications for treadmill test
Exclusion
- Intolerance or hypersensitivity to the components of the study drug.
- Intake of succinic acid, L-arginine, malic acid, fumaric acid, anticoagulants, or hormones (with the exception of insulin) within 6 weeks before the start of screening, or the use of these medications is scheduled within the patient's participation in the study
- Any severe disease or condition that may make it unsafe and/or impossible for the patient to participate in the study and/or lead to the inability of the patient to comply with the study procedures (including, but not limited to: renal failure, hepatic failure, blood diseases, psychiatric conditions, infections)
- History of malignancy (with the exception of basal cell skin cancer)
- Alcohol or drug abuse
- The presence of clinically significant decompensated cardiovascular diseases (unstable angina or stenocardia of functional class III and above, chronic heart failure III - IV class according to NYHA, uncontrolled arterial hypertension, acute cerebrovascular accident or acute myocardial infarction within 6 months prior to screening, unstable arrhythmias, deep venous thrombosis, stenosis of the internal carotid arteries \>70%, aortic aneurysm)
- Decompensation of the peripheral circulation: rest pain, trophic ulcers, gangrene
- Any other diseases that affect the assessment of walking distance and limit patient's physical activity
- The level of glycated hemoglobin (HbA1c) \>= 8%
- Planned reconstructive surgery on the limb vessels within 6 months from screening
- Amputation on one or both limbs or planned amputation within 6 months from screening
- Other circumstances impeding patient compliance with the schedule of procedures
- For patients applying or planning the use of NSAIDs: the inability to cancel the use of NSAIDs 12 hours before the treadmill test.
- The body mass index \>35
- Contraindications for conducting the treadmill test
- Heart rate is more than 80% of the maximum frequency (the maximum frequency is defined as 220 - age) at the moment of pain in the legs.
- Depression of an ST segment or the occurrence of sustained (lasting more than 30 seconds) cardiac rhythm or conduction disturbances during a treadmill test.
- Drop of systolic blood pressure during the first 5 minutes after the completion of the treadmill test
- Participation in another clinical study
- Pregnancy or breastfeeding
- Any other diseases / conditions in the stage of decompensation
- Employees of the research center and their family members.
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2019
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03861416
Start Date
March 16 2018
End Date
October 26 2019
Last Update
January 31 2020
Active Locations (19)
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1
Regional Clinical Hospital
Barnaul, Russia
2
Kursk City Clinical Emergency Hospital
Kursk, Russia
3
City Clinical Hospital № 15 named O.M. Filatov
Moscow, Russia
4
Medical and sanitary Department of the Ministry of Internal Affairs of the Russian Federation in Moscow
Moscow, Russia