"Unifuzol®" in Patients With Peripheral Arterial Disease

NCT03861416 | Completed Phase 2

• 1 other identifier: UNI-II-2016
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 19

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 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

Keywords

Peripheral Arterial Disease; Arterial Occlusive Disease; intermittent claudication

Outcome Measures

Primary Outcomes (1)

• 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).

  day 11, day 30

Study Arms (3)

Unifuzol® 1.4% 500 ml

EXPERIMENTAL

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

Unifuzol® 1.4% 250 ml

EXPERIMENTAL

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

Placebo 500 ml

PLACEBO COMPARATOR

Patients receive the infusion of placebo solution for intravenous infusions 500 ml IV daily for 10 days.

Drug: Placebo solution

Interventions

L-arginine 1.4% 500 ml DRUG

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%

Unifuzol® 1.4% 500 ml

L-arginine 1.4% 250 ml + placebo 250 ml DRUG

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

Unifuzol® 1.4% 250 ml

Placebo solution DRUG

Infusion of Ringer's solution by 500 ml (2 vials 250 ml each) IV daily for 10 days

Also known as: Ringer's solution

Placebo 500 ml

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (19)

Regional Clinical Hospital

Barnaul, Russia

Location

Kursk City Clinical Emergency Hospital

Kursk, Russia

Location

City Clinical Hospital № 15 named O.M. Filatov

Moscow, Russia

Location

Medical and sanitary Department of the Ministry of Internal Affairs of the Russian Federation in Moscow

Moscow, Russia

Location

City Clinical Hospital №2 of the Novosibirsk Region

Novosibirsk, Russia

Location

National Medical Research Center named after Academician E.N. Meshalkin

Novosibirsk, Russia

Location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, Russia

Location

Multidisciplinary center of modern medicine "Euromed"

Omsk, Russia

Location

Orenburg Regional Clinical Hospital

Orenburg, Russia

Location

Rostov State Medical University

Rostov-on-Don, Russia

Location

Ryazan Regional Clinical Cardiological dispensary

Ryazan, Russia

Location

City General Hospital №2

Saint Petersburg, Russia

Location

City Hospital №38 named after N.A. Semashko

Saint Petersburg, Russia

Location

Consultative and diagnostic center No. 85

Saint Petersburg, Russia

Location

Road Clinical Hospital of the Russian Railways Open Joint-Stock Company

Saint Petersburg, Russia

Location

St. Petersburg State Medical University n.a. I.P.Pavlov

Saint Petersburg, Russia

Location

Regional Clinical Cardiology Dispensary

Saratov, Russia

Location

Clinical hospital №10 of the Yaroslavl region

Yaroslavl, Russia

Location

Regional Clinical Hospital of the Yaroslavl region

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Arterial Occlusive Diseases; Intermittent Claudication

Interventions

Arginine; Ringer's Solution

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mikhail S Bogomolov, MD, PhD

  St. Petersburg State Medical University n.a. I.P.Pavlov

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 4, 2019
• Study Start: March 16, 2018
• Primary Completion: September 13, 2019
• Study Completion: October 26, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

RU (19)