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An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe | Clinical Trials | Clareo Health

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An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe

An Observational Study to Evaluate the Safety and Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe in Real World Patients With Primary Hypercholesterolemia

NCT05559606•Boryung Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

The study observes real world patients with primary hypercholesterolemia who receive a fixed dose combination therapy with atorvastatin and ezetimibe for 24 weeks; collects and analyzes data related to efficacy and safety of the therapy; and evaluates efficacy and safety of the fixed dose combination therapy with atorvastatin and ezetimibe.

Detailed Description

The prevalence of hypercholesterolemia, an atherosclerotic dyslipidemia which is the major cause of coronary artery diseases has risen. According to numerous studies, LDL-C is the key cause of atherosclerosis and it has been reported that treating patients to lower the LDL-C level will reduce the incidence of cardiovascular diseases. Currently, patients are classified into risk groups to receive a recommended therapy based on the defined criteria in Korea and Statin is the primary therapeutic agent recommended. However, there have been concerns that an increased dose of statins may result in hepatoxicity and reports that a combination therapy with ezetimibe without an additional dose of statins has clinical benefits. Ezetimibe is a drug that inhibits cholesterol absorption in the small intestine and reduces the LDL-C level. The therapeutic guideline, first of all, recommends combination therapy with ezetimibe among other drugs whose clinical benefits have been confirmed in cases where the target LDL-C level is not met with statins. The study observes real world patients with primary hypercholesterolemia who receive a fixed dose combination therapy with atorvastatin and ezetimibe for 24 weeks; collects and analyzes data related to efficacy and safety of the therapy; and evaluates efficacy and safety of the fixed dose combination therapy with atorvastatin and ezetimibe. During this study period, the scope of data to be collected is as follows: * Demographic data * Indication diagnosis and characteristics * Cardiovascular risk * Medical history * Statin medication * Preceding/Concomitant drug * Administration of fixed dose combination therapy with atorvastatin and ezetimibe * Collecting efficacy endpoints: Lipid profile(LDL-C, TC, TG, HDL-C, non-HDL-C) * Collecting safety endpoints: ADR, SAE, SADR, HbA1C, FPG, AST, ALT, CPK

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

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.
+1 more criteria

Locations (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Key Dates

Start Date

September 7, 2022

Primary Completion Date

July 30, 2025

Completion Date

July 30, 2025

Last Updated

September 12, 2025

Enrollment

1,839

ACTUAL participants

Conditions

Primary Hypercholesterolemia

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Primary HypercholesterolemiaMixed Dyslipidemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

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