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"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia

Primary Purpose

Combined Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
"Phospholipovit"
Placebo
Sponsored by
Institute of Biomedical Chemistry, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Combined Hyperlipidemia focused on measuring Phospholipid nanoparticles, non-HDL-C level, TG level

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Availability of signed and dated informed consent of the patient to participate in the study; Patients with moderate combined hyperlipidemia, defined as: Total cholesterol level 3 - 7 mmol/l, LDL-C 2.5 - 5 mmol/l, TG 1.7 - 4.5 mmol/l, and HDL-C < 1 mmol/l during screening for men and < 1.2 mmol/l for women; Patient consent to use reliable contraceptive methods throughout the study; The patient's ability to adequately cooperation. Exclusion Criteria: TG > 4.5 mmol/l; Total cholesterol >7 mmol/l; LDL cholesterol >5 mmol/l; Age less than 30 or older than 75; Diseases or metabolic disorders that can cause an increase in LDL-C, total cholesterol and TG (secondary dyslipidemia); Patients receiving high doses of statin drugs (rosuvastatin ≥40 mg, atorvastatin ≥80 mg); Any acute or exacerbation of chronic infectious diseases; Type 1 Diabetes mellitus; Glomerular filtration rate less than 30 ml/min/1.73 m2; Patients who have undergone acute conditions (infections, injuries, operations) in the period less than 2 months before the start of the study; Patients with severe dysfunction of the liver and/or kidneys, and/or other vital organs, accompanied by decompensation of their functions; diseases of the central nervous system, with severe impairment of cognitive and mnestic functions; Persistent increase in liver enzymes activity (transaminases) of unclear etiology or increased liver enzymes activity by 2 or more times from the upper limit of the norm; Alcohol abuse more than 5 units of alcohol per week (1 unit alcohol is equivalent to 0.325 liters beer, 130 ml wine, 30 ml alcohol); Drug use; A history of a positive HIV test result; Positive test result for hepatitis B and C, syphilis; A history of hypothyroidism or thyroid-stimulating hormone levels (TSH) exceeding > 1X upper limit of normal (ULN) during screening; History of oncological disease during the last 5 years; Patients diagnosed with porphyria; Patients diagnosed with myopathy; Clinically significant abnormal blood test results general urinalysis at screening; Hypersensitivity to phospholipids or any components of investigational drug; Indications for drug therapy a list of therapies prohibited during the study; Any other diseases or conditions that, in the opinion of the investigator, may distort the results of the study and limit the patient's participation in the study; Pregnancy and lactation; Patient participation in another clinical trial or use of any investigational drug during 1 month prior to inclusion in the study; Not using contraception for patients of reproductive age.

Sites / Locations

  • Federal State Budgetary Institution "National Medical Research Centre Of Cardiology" of the Ministry of Health of the Russian Federation
  • LLC "Nizhny Novgorod Medical clinic"
  • LLC "Medical Center for Diagnostics and prevention plus"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

"Phospholipovit"

Placebo

Arm Description

Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks

Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks

Outcomes

Primary Outcome Measures

Percentage change from baseline in non-HDL-C values
The efficacy is evaluated in terms of the percentage change from baseline in non-HDL-C values

Secondary Outcome Measures

Dynamics of change of total cholesterol level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of total cholesterol level compared with the baseline
Dynamics of change of LDL-C level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of LDL-C level compared with the baseline
Dynamics of change of HDL-C level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of HDL-C level compared with the baseline
Dynamics of change of TG level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of TG level compared with the baseline
Dynamics of change of VLDL-C level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of VLDL-C level compared with the baseline
Dynamics of change of Apo-A1 level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of Apo-A1 level compared with the baseline
Dynamics of change of Apo-B level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of Apo-B level compared with the baseline
Dynamics of change of LP (a) level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of LP (a) level compared with the baseline
Dynamics of change of atherogenic index compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of atherogenic index compared with the baseline
Dynamics of average hs-CRP level compared with the baseline
The efficacy is evaluated in terms of the dynamics of average hs-CRP level compared with the baseline
Change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline
The efficacy is evaluated in terms of the change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline (limited sample of patients)

Full Information

First Posted
February 1, 2023
Last Updated
February 14, 2023
Sponsor
Institute of Biomedical Chemistry, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT05742022
Brief Title
"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia
Official Title
A Randomized, Double-blind, Multicenter, Placebo-controlled Clinical Trial of Safety and Efficacy of "Phospholipovit" in Patients With Combined Hyperlipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biomedical Chemistry, Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
"Phospholipovit" vs placebo in patients with combined hyperlipidemia
Detailed Description
It is well known that atherosclerosis and its complications are the leading cause of morbidity and mortality in the world, and the high blood cholesterol is one of the leading risk factors for atherosclerosis. Among cholesterol-lowering agents, the most common are inhibitors of HMG-CoA reductase, so-called statins. Nevertheless, low attention is paid to the process responsible for cholesterol removing from the cells - the so-called "reverse cholesterol transport" (RCT). The major lipoproteins, involved in RCT, are high-density lipoproteins (HDL). The effectiveness of RCT is determined not only by the level of cholesterol in HDL, but also by the composition of HDL, in particular, by the content of phosphatidylcholine (PC) in HDL. Based on the original phospholipid composition, the Institute of Biomedical Chemistry developed the "Phospholipovit" - the aqueous medium of nanoemulsion of phospholipids with a particle size of 20-25 nm. The intestinal absorption of phospholipids nanoemulsion should contribute to the HDL enrichment by phospholipids, and, consequently, to the enhancement of RCT. A study of the safety and tolerability of the "Phospholipovit" in healthy patients has been completed. The "Phospholipovit" has demonstrated safety and tolerability. The main objective of this study is to evaluate the effectiveness and safety of "Phospholipovit", a powder for preparation of an oral solution, 500 mg compared with placebo in patients with combined hyperlipidemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Combined Hyperlipidemia
Keywords
Phospholipid nanoparticles, non-HDL-C level, TG level

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
At clinical centers, patients will be equally randomized by the "envelope method" into two groups to receive "Phospholipovit" or placebo. The drugs will be administered after the signed informed consent. "Phospholipovit" will be administered 500 mg orally 2 times a day, for 12 weeks. Placebo will be administered orally 2 times a day, for 12 weeks. All patients will be examined after 12 weeks.
Masking
ParticipantCare Provider
Masking Description
two or more parties are unaware of the intervention assignment.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Phospholipovit"
Arm Type
Experimental
Arm Description
Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
"Phospholipovit"
Intervention Description
500 mg orally 2 times a day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 mg orally 2 times a day, for 12 weeks
Primary Outcome Measure Information:
Title
Percentage change from baseline in non-HDL-C values
Description
The efficacy is evaluated in terms of the percentage change from baseline in non-HDL-C values
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Dynamics of change of total cholesterol level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of total cholesterol level compared with the baseline
Time Frame
week 12
Title
Dynamics of change of LDL-C level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of LDL-C level compared with the baseline
Time Frame
week 12
Title
Dynamics of change of HDL-C level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of HDL-C level compared with the baseline
Time Frame
week 12
Title
Dynamics of change of TG level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of TG level compared with the baseline
Time Frame
week 12
Title
Dynamics of change of VLDL-C level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of VLDL-C level compared with the baseline
Time Frame
week 12
Title
Dynamics of change of Apo-A1 level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of Apo-A1 level compared with the baseline
Time Frame
week 12
Title
Dynamics of change of Apo-B level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of Apo-B level compared with the baseline
Time Frame
week 12
Title
Dynamics of change of LP (a) level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of LP (a) level compared with the baseline
Time Frame
week 12
Title
Dynamics of change of atherogenic index compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of change of atherogenic index compared with the baseline
Time Frame
week 12
Title
Dynamics of average hs-CRP level compared with the baseline
Description
The efficacy is evaluated in terms of the dynamics of average hs-CRP level compared with the baseline
Time Frame
week 12
Title
Change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline
Description
The efficacy is evaluated in terms of the change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline (limited sample of patients)
Time Frame
week 12
Other Pre-specified Outcome Measures:
Title
Safety endpoint - Number and severity of serious adverse events (SAEs) and AEs in organs and systems
Description
The safety is evaluated in terms of the number and severity of SAEs and AEs in organs and systems
Time Frame
within 12 weeks
Title
Safety endpoint - The frequency of cases of early termination of participation in the study due to the development AE and SAE
Description
The safety is evaluated in terms of the frequency of cases of early termination of participation in the study due to the development AE and SAE
Time Frame
within 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Availability of signed and dated informed consent of the patient to participate in the study; Patients with moderate combined hyperlipidemia, defined as: Total cholesterol level 3 - 7 mmol/l, LDL-C 2.5 - 5 mmol/l, TG 1.7 - 4.5 mmol/l, and HDL-C < 1 mmol/l during screening for men and < 1.2 mmol/l for women; Patient consent to use reliable contraceptive methods throughout the study; The patient's ability to adequately cooperation. Exclusion Criteria: TG > 4.5 mmol/l; Total cholesterol >7 mmol/l; LDL cholesterol >5 mmol/l; Age less than 30 or older than 75; Diseases or metabolic disorders that can cause an increase in LDL-C, total cholesterol and TG (secondary dyslipidemia); Patients receiving high doses of statin drugs (rosuvastatin ≥40 mg, atorvastatin ≥80 mg); Any acute or exacerbation of chronic infectious diseases; Type 1 Diabetes mellitus; Glomerular filtration rate less than 30 ml/min/1.73 m2; Patients who have undergone acute conditions (infections, injuries, operations) in the period less than 2 months before the start of the study; Patients with severe dysfunction of the liver and/or kidneys, and/or other vital organs, accompanied by decompensation of their functions; diseases of the central nervous system, with severe impairment of cognitive and mnestic functions; Persistent increase in liver enzymes activity (transaminases) of unclear etiology or increased liver enzymes activity by 2 or more times from the upper limit of the norm; Alcohol abuse more than 5 units of alcohol per week (1 unit alcohol is equivalent to 0.325 liters beer, 130 ml wine, 30 ml alcohol); Drug use; A history of a positive HIV test result; Positive test result for hepatitis B and C, syphilis; A history of hypothyroidism or thyroid-stimulating hormone levels (TSH) exceeding > 1X upper limit of normal (ULN) during screening; History of oncological disease during the last 5 years; Patients diagnosed with porphyria; Patients diagnosed with myopathy; Clinically significant abnormal blood test results general urinalysis at screening; Hypersensitivity to phospholipids or any components of investigational drug; Indications for drug therapy a list of therapies prohibited during the study; Any other diseases or conditions that, in the opinion of the investigator, may distort the results of the study and limit the patient's participation in the study; Pregnancy and lactation; Patient participation in another clinical trial or use of any investigational drug during 1 month prior to inclusion in the study; Not using contraception for patients of reproductive age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander I. Archakov, MD, PhD
Organizational Affiliation
Institute of Biomedical Chemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal State Budgetary Institution "National Medical Research Centre Of Cardiology" of the Ministry of Health of the Russian Federation
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
LLC "Nizhny Novgorod Medical clinic"
City
Nizhny Novgorod
ZIP/Postal Code
603071
Country
Russian Federation
Facility Name
LLC "Medical Center for Diagnostics and prevention plus"
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia

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