ClinicalTrials.gg
RecruitingNCT07083206PIVOTALUpdated Oct 27, 2026

A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe

An observational study in Hypercholesterolemia and Dyslipidemias, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,500
Ages
19 Years and older
Sex
All
01

Study summary

The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.

02

Conditions studied

  • Hypercholesterolemia
  • Dyslipidemias
03

In context

Hypercholesterolemia

1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.

This study's planned enrollment of 4,500 is above the median of 1,000 across 144 observational studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who require administration of a fixed-dose combination of pitavastatin/ezetimibe for the treatment of hypercholesterolemia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 19 years or older
  • Patients diagnosed with hypercholesterolemia who have been stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months, and for whom switching to fixed-dose combination pitavastatin/ezetimibe has been clinically decided
  • Patients with available clinical laboratory test results related to efficacy and safety (TC, TG, HDL-C, LDL-C, , ALT, Cr/) within 12 months prior to switching to fixed-dose combination pitavastatin/ezetimibe (no changes in statin regimen or dosage during that period)
  • Individuals (or their legally authorized representatives) who voluntarily provide written to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Known or history of hypersensitivity to any component of the product
  • Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels
  • Patients with severe hepatic impairment, biliary obstruction, or cholestasis
  • Patients currently receiving cyclosporine treatment
  • Patients diagnosed with myopathy
  • Pregnant or breastfeeding women, or women who may be pregnant
  • Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rate of reaching the target LDL-C level

    Time frame: 12 months after administration

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data (IPD) due to confidentiality concerns and lack of applicable data-sharing infrastructure.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jul 2028, 36 months after the start.

Of 51 observational studies under Hypercholesterolemia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's planned 36 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2025
First posted
Jul 24, 2025
StartActual
Jul 29, 2025
Primary completionEst.
Jul 2028
CompletionEst.
Jan 2029
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07083206
Responsible party
Sponsor
First posted
Jul 24, 2025
Start date
Jul 29, 2025
Primary completion
Jul 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Hyunji Kim
Contact
hyunji.kim@ahn-gook.com
+82-2-3289-4215
Deok Kyu Cho
principal investigator · Severance Hospital

Oversight

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

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