A Phase 2 interventional study of L-arginine 1.4% 500 ml and L-arginine 1.4% 250 ml + placebo 250 ml in Peripheral Arterial Disease, sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. Completed at 19 sites in Russian Federation. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2020-01-31.
Sponsored by POLYSAN Scientific & Technological Pharmaceutical Company · Phase 2, Interventional, and Treatment
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 the lower extremities. The study recruits patients 40-79 years old with a confirmed diagnosis of chronic ischemia of the lower limb and a stable symptom of intermittent claudication that occurs when walking a distance of 100-299 meters. L-arginine improves microcirculation due to activation of nitrogen monoxide production and stimulates capillary blood flow, thus can probably improve the quality of life of patients with intermittent claudication. The criterion for treatment efficacy will be an increase in the maximum walking distance measures before and on the next day after the end of treatment course.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 360 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →POLYSAN Scientific & Technological Pharmaceutical Company is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Patients receive the infusion of investigational drug L-arginine 1.4% 500 ml IV daily for 10 days
Drug: L-arginine 1.4% 500 ml
Patients receive the infusion of L-arginine 1.4% 250 ml + placebo 250 ml IV daily for 10 days
Drug: L-arginine 1.4% 250 ml + placebo 250 ml
Patients receive the infusion of placebo solution for intravenous infusions 500 ml IV daily for 10 days.
Drug: Placebo solution
Infusion of L-arginine 1.4% solution by 500 ml (2 vials 250 ml each) IV daily for 10 days
Also known as: Unifuzol® 1.4%
Infusion of L-arginine 1.4% solution 250 ml IV daily for 10 days and placebo infusion by 250 ml IV daily for 10 days.
Also known as: Unifuzol® 1.4% 250 ml and placebo 250 ml
Infusion of Ringer's solution by 500 ml (2 vials 250 ml each) IV daily for 10 days
Also known as: Ringer's solution
Maximum walking distance
The change in the maximum walking distance on the next day (day 11) after the completion of treatment course and on day 30 in comparison with the initial value. The change will be expressed as the ratio of the natural logarithms of the maximum walking distance on day 11 and to the baseline value (day 1).
Time frame: day 11, day 30
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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POLYSAN Scientific & Technological Pharmaceutical Company