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Status unknownNCT03947866ZEUSUpdated Feb 16, 2023

Ezetimibe-Rosuvastatin Evaluation Study

An observational study in Hypercholesterolemia, Hyperlipidemias and Combinations of Drugs; Dependence, sponsored by Elpen Pharmaceutical Co. Inc.. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-02-16.

Sponsored by Elpen Pharmaceutical Co. Inc. · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
600
Ages
18 Years to 90 Years
Sex
All
01

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.

Read the 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.
02

Conditions studied

  • Hypercholesterolemia
  • Hyperlipidemias
  • Combinations of Drugs; Dependence
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's planned enrollment of 600 is below the median of 800 across 185 observational studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Elpen Pharmaceutical Co. Inc. is the lead sponsor of 43 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with hyperlcholesterolaemia

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. LDL-C

    Levels of LDL-C

    Time frame: 12 months

Secondary outcomes

  1. Lipidemic profile

    HDL-C↑ T-CHOL, Triglycerides measurements

    Time frame: 12 months

  2. Cardiovascular risk factor

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

    Time frame: 12 months

  3. Adverse Events

    Number of Adverse Events during the study.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Athens University Hospital HIPPOKRATEION
    Athens, Greece
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03947866
Lead sponsor
Elpen Pharmaceutical Co. Inc.
Responsible party
Sponsor
First posted
May 13, 2019
Start date
Sep 30, 2022
Primary completion
Sep 30, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Feb 16, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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