drugset / Trial / NCT04643093

Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

NCT04643093

Phase 3 Completed 390 enrolled Orient Pharma Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study is to evaluate whether the efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week treatment period.

Timeline

Start
2020-08-01
Primary completion
2021-08-19
Completion
2021-10-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ezetimibe Unknown 10 mg
Comparator Pitavastatin Small molecule 2 mg