Ezetimibe-Rosuvastatin Evaluation Study

Last updated: February 14, 2023
Sponsor: Elpen Pharmaceutical Co. Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT03947866
2022-ROSEZE-EL-160
  • Ages 18-90
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients who have not fully understood the study procedures and have not signed theconsent form.
  • Patients who are contraindicated for taking the drug according to the Summary ofProduct 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 serumtransaminases and any increase in serum transaminases that exceeds 3 times the normalupper 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

Total Participants: 600
Study Start date:
September 30, 2022
Estimated Completion Date:
September 30, 2023

Study 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.

Connect with a study center

  • Athens University Hospital HIPPOKRATEION

    Athens,
    Greece

    Active - Recruiting

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