Peripheral Arterial DiseasePhase 2NCT03861416
"Unifuzol®" in Patients With Peripheral Arterial Disease
A Phase 2 study testing L-arginine 1.4% 500 ml in people with Peripheral Arterial Disease, run by POLYSAN Scientific & Technological Pharmaceutical Company at 19 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- L-arginine 1.4% 500 ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 19 sitesRussia
- Study dates
- 16 Mar 2018to 26 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
- Heart rate is more than 80% of the maximum frequency (the maximum frequency is defined as 220 - age) at the moment of pain in the legs.
- Depression of an ST segment or the occurrence of sustained (lasting more than 30 seconds) cardiac rhythm or conduction disturbances during a treadmill test.
- Drop of systolic blood pressure during the first 5 minutes after the completion of the treadmill test
- Participation in another clinical study
- Pregnancy or breastfeeding
- Any other diseases / conditions in the stage of decompensation
- Employees of the research center and their family members.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Russia19 sites
Regional Clinical Hospital
Barnaul
Kursk City Clinical Emergency Hospital
Kursk
City Clinical Hospital № 15 named O.M. Filatov
Moscow
Medical and sanitary Department of the Ministry of Internal Affairs of the Russian Federation in Moscow
Moscow
City Clinical Hospital №2 of the Novosibirsk Region
Novosibirsk
National Medical Research Center named after Academician E.N. Meshalkin
Novosibirsk
State Novosibirsk Regional Clinical Hospital
Novosibirsk
Multidisciplinary center of modern medicine "Euromed"
Omsk
Orenburg Regional Clinical Hospital
Orenburg
Rostov State Medical University
Rostov-on-Don
Ryazan Regional Clinical Cardiological dispensary
Ryazan
City General Hospital №2
Saint Petersburg
City Hospital №38 named after N.A. Semashko
Saint Petersburg
Consultative and diagnostic center No. 85
Saint Petersburg
Road Clinical Hospital of the Russian Railways Open Joint-Stock Company
Saint Petersburg
St. Petersburg State Medical University n.a. I.P.Pavlov
Saint Petersburg
Regional Clinical Cardiology Dispensary
Saratov
Clinical hospital №10 of the Yaroslavl region
Yaroslavl
Regional Clinical Hospital of the Yaroslavl region
Yaroslavl
About this study
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Unifuzol® in Patients With Peripheral Arterial Disease
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
- Being tested
- L-arginine 1.4% 500 ml, L-arginine 1.4% 250 ml + placebo 250 ml, Placebo solution
- Keywords
- Peripheral Arterial Disease, Arterial Occlusive Disease, intermittent claudication
- Medical subject headings
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginine 1.4% 500 mlDrug
Also called Unifuzol® 1.4%
Infusion of L-arginine 1.4% solution by 500 ml (2 vials 250 ml each) IV daily for 10 days
L-arginine 1.4% 250 ml + placebo 250 mlDrug
Also called Unifuzol® 1.4% 250 ml and 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.
Placebo solutionDrug
Also called Ringer's solution
Infusion of Ringer's solution by 500 ml (2 vials 250 ml each) IV daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Unifuzol® 1.4% 500 ml | Experimental | Patients receive the infusion of investigational drug L-arginine 1.4% 500 ml IV daily for 10 days Receives: 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 Receives: 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. Receives: Drug: Placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 11, day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start16 Mar 2018
- Primary completion13 Sep 2019
- Study completion26 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail S Bogomolov, MD, PhD, Study director, St. Petersburg State Medical University n.a. I.P.Pavlov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861416
- Sponsor's protocol ID
- UNI-II-2016
- Status last verified
- Jan 2020
- First submitted
- 1 Mar 2019
- Last updated
- 31 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Unifuzol® in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03861416
- Acronym / sponsor ID
- UNI-II-2016
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Arterial Occlusive Disease, intermittent claudication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 26 Oct 2019 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unifuzol® 1.4% 500 ml | Experimental | Drug: L-arginine 1.4% 500 mlPatients receive the infusion of investigational drug L-arginine 1.4% 500 ml IV daily for 10 days |
| Unifuzol® 1.4% 250 ml | Experimental | Drug: L-arginine 1.4% 250 ml + placebo 250 mlPatients receive the infusion of L-arginine 1.4% 250 ml + placebo 250 ml IV daily for 10 days |
| Placebo 500 ml | Placebo comparator | Drug: Placebo solutionPatients receive the infusion of placebo solution for intravenous infusions 500 ml IV daily for 10 days. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginine 1.4% 500 mlAlso: Unifuzol® 1.4%Infusion of L-arginine 1.4% solution by 500 ml (2 vials 250 ml each) IV daily for 10 days | Drug | Unifuzol® 1.4% 500 ml |
| L-arginine 1.4% 250 ml + placebo 250 mlAlso: Unifuzol® 1.4% 250 ml and placebo 250 mlInfusion 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 | Unifuzol® 1.4% 250 ml |
| Placebo solutionAlso: Ringer's solutionInfusion of Ringer's solution by 500 ml (2 vials 250 ml each) IV daily for 10 days | Drug | Placebo 500 ml |
Primary outcome
Maximum walking distance
Time frame: day 11, day 30
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail S Bogomolov, MD, PhD study director
St. Petersburg State Medical University n.a. I.P.Pavlov
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-arginine 1.4% 500 ml in people with Peripheral Arterial Disease, run by POLYSAN Scientific & Technological Pharmaceutical Company at 19 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum walking distance (time frame: day 11, day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.