NCT03947866

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
3.4 years until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

May 10, 2019

Last Update Submit

February 14, 2023

Conditions

HypercholesterolemiaHyperlipidemiasCombinations of Drugs; Dependence

Outcome Measures

Primary Outcomes (1)

  • LDL-C

    Levels of LDL-C

    12 months

Secondary Outcomes (3)

  • Lipidemic profile

    12 months

  • Cardiovascular risk factor

    12 months

  • Adverse Events

    12 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hyperlcholesterolaemia

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athens University Hospital HIPPOKRATEION

Athens, Greece

RECRUITING

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 13, 2019

Study Start

September 30, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

GR(1)