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

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Sep 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination therapy using two medications, atorvastatin and ezetimibe, to help lower cholesterol levels in patients with a condition called primary hypercholesterolemia. The goal is to see how safe and effective this fixed dose combination is over a period of 24 weeks. Researchers are looking for participants who are at least 19 years old and have not previously taken this specific combination therapy. Eligible participants must also have cholesterol levels that have not reached the target goals set for their risk group, which can include various health conditions.

If you choose to participate, you'll be closely monitored for any side effects and how well the treatment works. It's important that participants understand the trial and are committed to completing it. However, certain individuals, such as those with serious liver or kidney problems, pregnant women, or those currently involved in other clinical trials, will not be able to join. This study is currently recruiting participants, so if you're interested and meet the criteria, you could contribute to important research that may help many others with similar health issues.

Gender

ALL

Eligibility criteria

• 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.