主要目的：在健康受试者体内，在空腹条件下以乐普制药科技有限公司生产的依折麦布匹伐他汀钙片（规格：10mg/2mg）为试验药物，以MSD Pharma（Singapore）Pte. Ltd.持证原研进口的依折麦布片（商品名：益适纯®；规格：10mg）及 Kowa Company, Ltd. 持证原研进口匹伐他汀钙片（商品名：力清之®；规格 2mg）为参照药物，研究健康受试者口服试验药物、参照药物后的药代动力学特征，评价试验药物与参照药物是否具有生物等效性。次要目的：观察健康受试者口服试验药物、参照药物的安全性及耐受性。

[Translation]

Primary objective: In healthy subjects, under fasting conditions, ezetimibe and pitavastatin calcium tablets (specifications: 10mg/2mg) produced by Lepu Pharmaceutical Technology Co., Ltd. were used as test drugs, and ezetimibe tablets (trade name: Yishichun®; specification: 10mg) imported with a license by MSD Pharma (Singapore) Pte. Ltd. and pitavastatin calcium tablets (trade name: Liqingzhi®; specification 2mg) imported with a license by Kowa Company, Ltd. were used as reference drugs to study the pharmacokinetic characteristics of the test and reference drugs after oral administration in healthy subjects, and to evaluate whether the test and reference drugs are bioequivalent. Secondary objective: To observe the safety and tolerability of the test and reference drugs after oral administration in healthy subjects.

Start Date20 Sep 2022

Sponsor / Collaborator

Lepu Pharmaceutical Technology Co., Ltd.

NCT04289649 / CompletedPhase 3

A Phase III, Multicenter, Randomized, Clinial Trial to Evaluate the Efficacy and Safety of K-924 in Patienta With Hypercholesterolemia.

A multicenter, active-controlled, randomized, double-blind comparative study to compare the efficacy and safety of K-924 LD tablet or K-924 HD tablet to pitavastatin 2 mg or 4 mg in patienta with hypercholesterolemia.

Start Date02 Apr 2020

Sponsor / Collaborator

Kowa Co., Ltd.

NCT04289662 / CompletedPhase 3

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.

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.

Start Date23 Mar 2020

Sponsor / Collaborator

Kowa Co., Ltd.

100 Clinical Results associated with Ezetimibe/Pitavastatin Calcium

100 Translational Medicine associated with Ezetimibe/Pitavastatin Calcium

100 Patents (Medical) associated with Ezetimibe/Pitavastatin Calcium

Literatures (Medical) associated with Ezetimibe/Pitavastatin Calcium

01 Mar 2024·Journal of atherosclerosis and thrombosis

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

Article

Author: Yokote, Koutaro ; Tsujita, Kenichi ; Suganami, Hideki ; Kamei, Ryo ; Ako, Junya ; Tanigawa, Ryohei

AIM:

Ezetimibe administration with ongoing statin therapy is an effective option for further lowering low-density lipoprotein cholesterol (LDL-C) levels. Thus, we investigated the long-term efficacy and safety of fixed-dose combination of pitavastatin/ezetimibe (K-924 LD: 2 mg/10 mg; K-924 HD: 4 mg/10 mg).

METHODS:

We conducted a phase III, multicenter, open-label trial involving patients with hypercholesterolemia receiving pitavastatin (2 or 4 mg) who had not achieved their LDL-C management target. Patients were enrolled into the K-924 LD and HD groups based on whether they had received pitavastatin 2 and 4 mg, respectively, and treated for 52 weeks. K-924 was administered orally once daily. The primary objective was to examine the percent change in LDL-C from baseline at week 52 with last observation carried forward imputation (LOCF) in all patients.

RESULTS:

Of the 109 patients evaluated, 62 and 47 were assigned to the K-924 LD and HD groups, respectively. In all patients, LDL-C decreased by -30.3±14.3% (p＜0.001) from baseline (134.4±37.9 mg/dL). Consequently, 91.8% and 37.5% of the patients for primary and secondary prevention reached their LDL-C management target, respectively. These results were consistent in both the K-924 LD and HD groups. In the safety analysis, a single adverse drug reaction occurred in a patient in the K-924 HD group.

CONCLUSION:

After replacing pitavastatin monotherapy, K-924 was found to be effective and well-tolerated over 52 weeks. Thus, K-924 can contribute to intensifying LDL-C-lowering therapy without increasing the number of medications.

100 Deals associated with Ezetimibe/Pitavastatin Calcium

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hypercholesterolemia	JP	Kowa Co., Ltd.	26 Sep 2022
Hyperlipoproteinemia Type II	JP	Kowa Co., Ltd.	26 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Homozygous familial hypercholesterolemia	Phase 1	CN	Lepu Pharmaceutical Technology Co., Ltd.	20 Sep 2022
Primary hypercholesterolemia	Phase 1	CN	Lepu Pharmaceutical Technology Co., Ltd.	20 Sep 2022

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