NCT03861416

"Unifuzol®" in Patients With Peripheral Arterial Disease

A Multicentre, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Unifuzol® in Patients With Peripheral Arterial Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company · Industry
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	L-arginine 1.4% 500 ml	Infusion of L-arginine 1.4% solution by 500 ml (2 vials 250 ml each) IV daily for 10 days
DRUG	L-arginine 1.4% 250 ml + placebo 250 ml	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.
DRUG	Placebo solution	Infusion of Ringer's solution by 500 ml (2 vials 250 ml each) IV daily for 10 days

Timeline

• Start date: 2018-03-16
• Primary completion: 2019-09-13
• Completion: 2019-10-26
• First posted: 2019-03-04
• Last updated: 2020-01-31

Locations

19 sites across 1 country: Russia