Ezetimibe-Rosuvastatin Evaluation Study

Recruiting

• Conditions: Hypercholesterolemia; Hyperlipidemias; Combinations of Drugs; Dependence

• Registration Number: NCT03947866
• Lead Sponsor: Elpen Pharmaceutical Co. Inc.

Brief Summary

Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in achieving the target plasma LCL-C level.

Detailed Description

Additional study objectives:

1. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia with respect to changes in the rest of the lipid profile (HDL-C, TC, TG).

2. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-HDL cholesterol (non-HDL - cholesterol) levels.

3. The assessment of the achievement of the LCL-C target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category.

4. Assessing patient safety throughout treatment.

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2022-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Adult patients who have voluntarily consented to participate in the study.
• Adult patients who are already on treatment with the stable combination of ezetimibe-rosuvastatin (Lipopen), at the discretion of the treating physician.
• Adult patient adequately controlled with rosuvastatin and ezetimibe according to ESC / EAS 2019 guidelines.

Exclusion Criteria

• Patients who have not fully understood the study procedures and have not signed the consent form.
• Patients who are contraindicated for taking the drug according to the Summary of Product Characteristics (MSF) of the study drug.

Hypersensitivity to the active substances or to any of the excipients of Lipopen.

• Pregnancy and breastfeeding.
• Active liver disease involving unexplained, persistent increases in serum transaminases and any increase in serum transaminases that exceeds 3 times the normal upper limit (ULN) or unexplained persistent increases in serum transaminases.
• Patient with severe renal impairment (creatinine clearance <30 ml / min).
• Patient with myopathy
• Patient receiving concomitant treatment with cyclosporine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LDL-C	12 months	Levels of LDL-C

Secondary Outcome Measures

Name	Time	Method
Lipidemic profile	12 months	HDL-C↑ T-CHOL, Triglycerides measurements
Cardiovascular risk factor	12 months	Response of patients vs target of total cardiovascular risk to which they belong.
Adverse Events	12 months	Number of Adverse Events during the study.

Trial Locations

Locations (1)

Athens University Hospital HIPPOKRATEION; 🇬🇷 Athens, Greece