Real-World check: combo cholesterol pill works in daily practice
NCT ID NCT05559606
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
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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
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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 Hide 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.
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
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Other studies related to the condition(s) this trial covers.
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