"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia

NCT05742022 | Completed Phase 2 DMC

• 1 other identifier: 05F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

"Phospholipovit" vs placebo in patients with combined hyperlipidemia

Conditions

Combined Hyperlipidemia

Keywords

Phospholipid nanoparticles; non-HDL-C level; TG level

Outcome Measures

Primary Outcomes (1)

• 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

  week 12

Secondary Outcomes (11)

• Dynamics of change of total cholesterol level compared with the baseline

  week 12

• Dynamics of change of LDL-C level compared with the baseline

  week 12

• Dynamics of change of HDL-C level compared with the baseline

  week 12

• Dynamics of change of TG level compared with the baseline

  week 12

• Dynamics of change of VLDL-C level compared with the baseline

  week 12

Other Outcomes (2)

• Safety endpoint - Number and severity of serious adverse events (SAEs) and AEs in organs and systems

  within 12 weeks

• Safety endpoint - The frequency of cases of early termination of participation in the study due to the development AE and SAE

  within 12 weeks

Study Arms (2)

"Phospholipovit"

EXPERIMENTAL

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

Drug: "Phospholipovit"

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

"Phospholipovit" DRUG

500 mg orally 2 times a day, for 12 weeks

"Phospholipovit"

Placebo DRUG

500 mg orally 2 times a day, for 12 weeks

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Institute of Biomedical Chemistry, Russia: lead

Study Sites (3)

Federal State Budgetary Institution "National Medical Research Centre Of Cardiology" of the Ministry of Health of the Russian Federation

Moscow, 121552, Russia

Location

LLC "Nizhny Novgorod Medical clinic"

Nizhny Novgorod, 603071, Russia

Location

LLC "Medical Center for Diagnostics and prevention plus"

Yaroslavl, 150040, Russia

Location

Study Officials

• Alexander I. Archakov, MD, PhD

  Institute of Biomedical Chemistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: two or more parties are unaware of the intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 23, 2023
• Study Start: January 1, 2016
• Primary Completion: June 20, 2018
• Study Completion: December 20, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)