NCT03861416

"Unifuzol®" in Patients With Peripheral Arterial Disease

Completed Phase 2 Last updated 31 January 2020

What this trial tests

Phase 2 trial testing L-arginine 1.4% 500 ml in Peripheral Arterial Disease in 360 participants. Completed in 26 October 2019.

Timeline

16 March 2018

Primary endpoint
13 September 2019

26 October 2019

Quick facts

Lead sponsor	POLYSAN Scientific & Technological Pharmaceutical Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	360
Start date	16 March 2018
Primary completion	13 September 2019
Estimated completion	26 October 2019
Sites	19 locations across Russia

Drugs / interventions tested

• L-arginine 1.4% 500 ml — full drug profile →
• L-arginine 1.4% 250 ml + placebo 250 ml — full drug profile →
• Placebo solution

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

POLYSAN Scientific & Technological Pharmaceutical Company — full company profile →

Who can join

Adults 40 to 79, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Therapeutic angiogenesis-based strategy for peripheral artery disease.
   Han J, Luo L, Marcelina O, Kasim V, et al · · 2022 · cited 46× · PMID 35836800 · DOI 10.7150/thno.74785