HypercholesterolemiaZEUSNCT03947866
Ezetimibe-Rosuvastatin Evaluation Study
An observational study of Hypercholesterolemia and Hyperlipidemias, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemias, Combinations of Drugs; Dependence
- How many people
- 600 participants
- Where
- 1 siteGreece
- Study dates
- 30 Sep 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hyperlcholesterolaemia
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Athens University Hospital HIPPOKRATEION
Athens
CHARALAMPOS VLAHOPOULOS, 0030 213 208.8000, cvlachop@med.uoa.gr
About this study
Official title: An Observational Clinical Study to Evaluate the Effectiveness of Fixed-dose Combination of eZEtimibe-rosUvaStatin.
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:
- 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).
- Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-HDL cholesterol (non-HDL - cholesterol) levels.
- The assessment of the achievement of the LCL-C target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category.
- Assessing patient safety throughout treatment.
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C
Levels of LDL-C
Measured: 12 months
Secondary outcomes (3)
Lipidemic profile
HDL-C↑ T-CHOL, Triglycerides measurements
Measured: 12 months
Cardiovascular risk factor
Response of patients vs target of total cardiovascular risk to which they belong.
Measured: 12 months
Adverse Events
Number of Adverse Events during the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start30 Sep 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947866
- Sponsor's protocol ID
- 2022-ROSEZE-EL-160
- Acronym
- ZEUS
- Status last verified
- Feb 2023
- First submitted
- 10 May 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Study to Evaluate the Effectiveness of Fixed-dose Combination of eZEtimibe-rosUvaStatin.
- ClinicalTrials.gov ID
- NCT03947866
- Acronym / sponsor ID
- ZEUS / 2022-ROSEZE-EL-160
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in achieving the target plasma LCL-C level.
Detailed description
Additional study objectives:
- 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).
- Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-HDL cholesterol (non-HDL - cholesterol) levels.
- The assessment of the achievement of the LCL-C target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category.
- Assessing patient safety throughout treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hyperlcholesterolaemia
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LDL-C
Time frame: 12 months
Levels of LDL-C
3 secondary outcomes
Lipidemic profile
Time frame: 12 months
Cardiovascular risk factor
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Hyperlipidemias, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.