Primary Hypercholesterolemia Clinical Trial
Official title:
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
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.
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03571087 -
Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT00776321 -
Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
|
Phase 2 | |
| Recruiting |
NCT05399992 -
Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD
|
||
| Withdrawn |
NCT05798390 -
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
|
||
| Completed |
NCT00724477 -
Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)
|
||
| Completed |
NCT00249249 -
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
|
Phase 3 | |
| Recruiting |
NCT05657574 -
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT03516955 -
Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting
|
||
| Completed |
NCT02941848 -
Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01012219 -
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
|
Phase 1 | |
| Completed |
NCT05131997 -
A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A
|
Phase 3 | |
| Terminated |
NCT03433755 -
Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
|
Phase 3 | |
| Completed |
NCT00867165 -
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
|
Phase 3 | |
| Active, not recruiting |
NCT03952169 -
Effect of Probiotics on Lipid Management
|
N/A | |
| Terminated |
NCT01335997 -
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
|
Phase 3 | |
| Completed |
NCT02087917 -
A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
|
Phase 2 | |
| Completed |
NCT00704535 -
Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
|
||
| Recruiting |
NCT06314919 -
A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib
|
||
| Terminated |
NCT01274559 -
Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
|
Phase 3 | |
| Completed |
NCT00941603 -
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
|
Phase 2 |