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。

开始日期2022-09-20

申办/合作机构

乐普制药科技有限公司

NCT04289649 / Completed临床3期

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.

开始日期2020-04-02

申办/合作机构

Kowa Co., Ltd.

NCT04289662 / Completed临床3期

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.

开始日期2020-03-23

申办/合作机构

Kowa Co., Ltd.

100 项与依折麦布匹伐他汀钙相关的临床结果

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100 项与依折麦布匹伐他汀钙相关的转化医学

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100 项与依折麦布匹伐他汀钙相关的专利（医药）

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项与依折麦布匹伐他汀钙相关的文献（医药）

2024-03-01·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

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

AIMEzetimibe 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).METHODSWe 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.RESULTSOf 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.CONCLUSIONAfter 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 项与依折麦布匹伐他汀钙相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
高胆固醇血症	日本	Kowa Co., Ltd.	2022-09-26
II型高脂蛋白血症	日本	Kowa Co., Ltd.	2022-09-26
原发性高胆固醇血症	韩国	JW PHARMACEUTICAL Corp.	2021-07-28

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适应症	最高研发状态	国家/地区	公司	日期
纯合子家族性高胆固醇血症	临床1期	中国	乐普制药科技有限公司	2022-09-20
原发性高胆固醇血症	临床1期	中国	乐普制药科技有限公司	2022-09-20
高胆固醇血症	临床申请批准	中国	浙江新东港生物科技有限公司	2022-04-20