Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, Dyslipidemia, Statin Monotherapy, LDL Cholesterol, Pitavastatin and Ezetimibe Combination, Observational Study, Switching Study
Brief summary
A Multi-center, Open-label, Observational Study to evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe after switching from Statin Monotherapy to Pitavastatin/Ezetimibe in patients with Hypercholesterolemia
Detailed description
A Multi-center, Open-label, Observational Study
Interventions
None listed
Sponsors
JW Pharmaceutical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C level | From enrollment to the end of treatment at 24 weeks | Percent change from baseline in LDL-C level at Week 24 |
Countries
South Korea
Outcome results
None listed