New combo pill may lower cholesterol better than statins alone
NCT ID NCT07445542
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study looked at nearly 7,000 adults with high cholesterol who switched from taking a statin alone to a combination pill containing Pitavastatin and Ezetimibe. The main goal was to see how much their LDL (bad) cholesterol dropped after 24 weeks. The study was observational, meaning doctors decided on the switch, and no comparison group was used.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pitavastatin/Ezetimibe combination pill
- What this could lead to
- If successful, this could confirm that switching to a combination pill helps lower cholesterol more effectively than statins alone.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less reliable. It also does not test long-term heart health benefits.
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
-
6,927 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
-
May 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
The study population includes adult patients (≥19 years) with hypercholesterolemia who are receiving routine clinical care at multiple centers in South Korea. The participants are those who have maintained a stable dose of statin monotherapy for at least 8 weeks and are switching to Pitavastatin/Ezetimibe as determined by the investigator. This observational study aims to reflect real-world clinical outcomes in patients undergoing this medication switch, provided they meet all eligibility criteria and provide written informed consent.
- 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 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: * Adults (≥19 years) with hypercholesterolemia. * On a stable dose of statin monotherapy for at least 8 weeks. * Scheduled to switch to Pitavastatin/Ezetimibe per investigator's decision. * Provided voluntary written informed consent. Exclusion Criteria: * Use of other lipid-lowering therapies within 4 weeks before screening. * History of clinically significant laboratory abnormalities within 1 year. * Participation in other clinical trials within 4 weeks. * Contraindications to Pitavastatin/Ezetimibe
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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
-
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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