K-924 Phase III Long Term Study

Phase 3 Completed 110 enrolled Kowa Company, Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

A Multicenter, Open-label Study to Evaluate 52 weeks long term Efficacy and Safety of K-924 in Patients with hypercholesterolemia who were treated with pitavastatin 2 mg or 4 mg.

Timeline

Start: 2020-03-23
Primary completion: 2021-08-07
Completion: 2021-08-07

Publications

Results Ako J, Yokote K, Tsujita K, Tanigawa R, Kamei R, Suganami H. Long-term Efficacy and Safety of K-924 Pitavastatin/Ezetimibe Fixed-dose Combination in Patients with Hypercholesterolemia: A Phase III, Multi-center, Open-label Trial. J Atheroscler Thromb. 2024 Mar 1;31(3):288-305. doi: 10.5551/jat.64272. Epub 2023 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezetimibe	Unknown	10 mg	Oral
Subject	Pitavastatin	Small molecule	2 mg	Oral
Subject	Pitavastatin	Small molecule	4 mg	Oral

K-924 Phase III Long Term Study

Summary

Timeline

Publications

Drugs

Indications