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ZEUS: Ezetimibe-Rosuvastatin Evaluation Study

Sponsor
Elpen Pharmaceutical Co. Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT03947866
Collaborator
(none)
600
Enrollment
1
Location
12
Anticipated Duration (Months)
50
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    An Observational Clinical Study to Evaluate the Effectiveness of Fixed-dose Combination of eZEtimibe-rosUvaStatin.
    Anticipated Study Start Date :
    Sep 30, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. LDL-C [12 months]

      Levels of LDL-C

    Secondary Outcome Measures

    1. Lipidemic profile [12 months]

      HDL-C↑ T-CHOL, Triglycerides measurements

    2. Cardiovascular risk factor [12 months]

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

    3. Adverse Events [12 months]

      Number of Adverse Events during the study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Athens University Hospital Athens Greece

    Sponsors and Collaborators

    • Elpen Pharmaceutical Co. Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elpen Pharmaceutical Co. Inc.
    ClinicalTrials.gov Identifier:
    NCT03947866
    Other Study ID Numbers:
    • 2022-ROSEZE-EL-160
    First Posted:
    May 13, 2019
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypercholesterolemia
    Hyperlipidemias

    Study Results

    No Results Posted as of May 25, 2022