Ezetimibe-Rosuvastatin Evaluation Study

Hypercholesterolemia Clinical Trial

— ZEUS  

Official title:

An Observational Clinical Study to Evaluate the Effectiveness of Fixed-dose Combination of eZEtimibe-rosUvaStatin.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03947866
• Other study ID #: 2022-ROSEZE-EL-160
• Status: Recruiting
• Start date: September 30, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Combinations of Drugs; Dependence
• Hypercholesterolemia
• Hyperlipidemias

Locations

Country	Name	City	State
Greece	Athens University Hospital HIPPOKRATEION	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C	Levels of LDL-C	12 months
Secondary	Lipidemic profile	HDL-C? T-CHOL, Triglycerides measurements	12 months
Secondary	Cardiovascular risk factor	Response of patients vs target of total cardiovascular risk to which they belong.	12 months
Secondary	Adverse Events	Number of Adverse Events during the study.	12 months