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Real-World check: combo cholesterol pill works in daily practice

NCT ID NCT05559606

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study observed 1,839 adults with primary high cholesterol who were prescribed a fixed-dose combination of atorvastatin and ezetimibe for 24 weeks. Researchers collected data on how well the pill lowered LDL cholesterol and tracked any safety issues. The goal was to see if this combo therapy works as well in everyday clinics as it does in controlled trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atorvastatin and ezetimibe combination pill
What this could lead to
If results are positive, this could confirm that the fixed-dose combo pill is a safe and effective option for managing high cholesterol in everyday patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only lasted 24 weeks, so long-term safety and benefits are not assessed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,839 people

The number who actually took part.

Started

Sep 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with primary hypercholesterolemia that require a fixed dose combination therapy with Atorvastatin and Ezetimibe

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Those who are briefed about the clinical trial objectives and methods, and express their consent to participate in the trial by signing a written consent on the use of their personal information. 2. Any male/female subjects 19 years old or older. 3. Those who will be given for the first time a fixed dose combination therapy with atorvastatin and ezetimibe to treat primary hypercholesterolemia. 4. Those with levels of total cholesterol, LDL-C, HDL-C, non-HDL-C and TG confirmed within 2 weeks prior to the registration. 5. Those who failed to reach to the target LDL-C level per risk group based on the risk group classification specified in the therapeutic guideline for dyslipidemia (2018). \[Risk Group, Target LDL-C (mg/dL) Level\] * Very High Risk \<70 * Coronary artery disease * Atherosclerotic ischemic stroke and transient cerebral ischemic attack * Peripheral arterial disease * High Risk \<100 * Carotid disease (When significant carotid artery stenosis is diagnosed) * Abdominal aneurysm * Diabetes (For patients with major risk factors such as damage to target organs or cardiovascular diseases, the target level may be lowered based on the patient conditions) * Moderate Risk \<130 * 2 or more major risk factors(May include age (45 years old for male subjects and 55 years old for female subjects), family history of initial coronary artery disease stage, hypertension, smoking, low HDL-C) * Low Risk \<160 * 1 or less major risk factors(May include age (45 years old for male subjects and 55 years old for female subjects), family history of initial coronary artery disease stage, hypertension, smoking, low HDL-C) 6. Those who fully understand the clinical trial, are cooperative throughout the trial and capable of participating in the trial until it ends. Exclusion Criteria: 1. Those who are hypersensitive to major ingredients or other ingredients of the investigational drug. 2. Hypertriglyceridemia patients whose triglyceride level is 400mg/dL or higher under fasting conditions. 3. Patients with serious hepatopathy (whose ALT or AST level is more than twice the upper limit of normal (ULN)). 4. Patients with serious nephropathy. 5. Those who have medical history of myopathy and rhabdomyolysis. 6. Female patients who are pregnant, suspected to be pregnant or breastfeeding. 7. Those who are administrating glecaprevir and pibrentasvir. 8. The drug contains lactose, thus those who have genetic problems, including galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption. 9. Those who are currently participating in other clinical trials (any trials with drugs or medical devices) or who have been administered with investigational drugs of other clinical trials within 4 weeks from the baseline. However, those participating in non-interventional trials or being observed after the drug administration is complete may take part in the trial. 10. Those who are currently hospitalized or are expected to be hospitalized. 11. Those who are suffering from severe or unstable medical and mental illnesses that may impact the trial as assessed by the investigators.

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.