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

NCT05559606 | Completed

• 1 other identifier: BR-EAC-OS-401
• Study Type: observational
• Target: 1,839
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Hypercholesterolemia

Keywords

Hypercholesterolemia; Atorvastatin; Ezetimibe

Outcome Measures

Primary Outcomes (1)

• Rate of reaching the target LDL-C level

  Rate of reaching the target LDL-C level at Week 24

  Week 24

Secondary Outcomes (2)

• Rate of reaching the target LDL-C level

  Week 12

• Rate of change compared to the baseline when it comes to the level of TC, TG, LDL-C, HDL-C and non-HDL-C

  Week 12 and Week 24

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• Any male/female subjects 19 years old or older.
• Those who will be given for the first time a fixed dose combination therapy with atorvastatin and ezetimibe to treat primary hypercholesterolemia.
• Those with levels of total cholesterol, LDL-C, HDL-C, non-HDL-C and TG confirmed within 2 weeks prior to the registration.
• 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

You may not qualify if:

• Those who are hypersensitive to major ingredients or other ingredients of the investigational drug.
• Hypertriglyceridemia patients whose triglyceride level is 400mg/dL or higher under fasting conditions.
• Patients with serious hepatopathy (whose ALT or AST level is more than twice the upper limit of normal (ULN)).
• Patients with serious nephropathy.
• Those who have medical history of myopathy and rhabdomyolysis.
• Female patients who are pregnant, suspected to be pregnant or breastfeeding.
• Those who are administrating glecaprevir and pibrentasvir.
• The drug contains lactose, thus those who have genetic problems, including galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.
• 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.
• Those who are currently hospitalized or are expected to be hospitalized.
• Those who are suffering from severe or unstable medical and mental illnesses that may impact the trial as assessed by the investigators.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• MyungSook Hong

  Boryung Co.,Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: September 7, 2022
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)