Ezetimibe-Rosuvastatin Evaluation Study

Elpen Pharmaceutical Co. Inc.600 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Hypercholesterolemia Hyperlipidemias Combinations of Drugs; Dependence

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Athens University Hospital HIPPOKRATEION

Athens, Greece

RECRUITING

Outcomes

Primary Outcomes

LDL-C

Levels of LDL-C

Time frame: 12 months

Secondary Outcomes

Lipidemic profile

HDL-C↑ T-CHOL, Triglycerides measurements

Time frame: 12 months

Cardiovascular risk factor

Response of patients vs target of total cardiovascular risk to which they belong.

Time frame: 12 months

Adverse Events

Number of Adverse Events during the study.

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.