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"Unifuzol®" in Patients With Peripheral Arterial Disease

NCT03861416 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-01-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • POLYSAN Scientific & Technological Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Mikhail S Bogomolov, MD, PhD · St. Petersburg State Medical University n.a. I.P.Pavlov

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2019-09-13
Completion
2019-10-26

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861416 on ClinicalTrials.gov