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.

Start Date01 Aug 2020

Sponsor / Collaborator

Orient Pharma Co., Ltd.

100 Clinical Results associated with 1PC111

100 Translational Medicine associated with 1PC111

100 Patents (Medical) associated with 1PC111

Literatures (Medical) associated with 1PC111

01 Oct 2022·Clinical Therapeutics

Effect of 1PC111, a Fixed-dose Combination of Pitavastatin and Ezetimibe, Versus Pitavastatin or Ezetimibe Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia or Mixed Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase III Study

Article

Author: Lee, I-Te ; Huang, Chun-Yao ; Chou, Ming-Ting ; Lu, Chieh-Hsiang ; Sheu, Wayne Huey-Herng ; Jong, Gwo-Ping ; Hsieh, Chang-Hsun ; Chao, Ting-Hsing ; Chen, Ching-Pei ; McGirr, Anthony

PURPOSEThis study aimed to show that the efficacy of 1PC111 is superior to that of either ezetimibe or pitavastatin alone (monotherapy) for the treatment of hypercholesterolemia.METHODSThis was a multicenter, randomized, double-blind, Phase III study. Patients with hypercholesterolemia or mixed dyslipidemia were randomized to receive 1PC111 (which was a fixed-dose combination of pitavastatin 2 mg and ezetimibe 10 mg), pitavastatin 2 mg, or ezetimibe 10 mg daily for 12 weeks. The primary end point was the difference in the percent change in LDL-C from baseline to week 12 between the 1PC111 and each monotherapy group. The secondary end points were the percent change in other lipid profiles from baseline to each visit. All patients were assessed for adverse events until end of study.FINDINGSA total of 388 patients were randomly assigned to the 1PC111 (n = 128), pitavastatin (n = 132), or ezetimibe (n = 128) group. Generally, baseline characteristics were similar among the 3 groups. A statistically significant decrease in the LDL-C level at week 12 was observed in the 1PC111 group (-50.50% [14.9%]) compared with either the pitavastatin (-36.11% [11.4%]; P < 0.001) or ezetimibe (-19.85% [12.4%]; P < 0.001) group. Also, there was a statistically significant difference between 1PC111 and each monotherapy group in the reduction in total cholesterol, non-HDL-C, and apolipoprotein B levels. Moreover, there was a trend toward more efficient lowering of LDL-C levels in elderly patients (age ≥65 years) than in younger patients (age <65 years) by 1PC111 treatment. In patients given a class I recommendation for atherosclerotic cardiovascular disease prevention, the percentage of patients achieving the LDL-C target of <100 mg/dL at week 12 was significantly higher in the 1PC111 group than in both monotherapy groups (P < 0.001). Overall, the incidence of adverse events was similar among 3 groups.IMPLICATIONS1PC111 was more effective in improving lipid profiles and achieving the LDL-C goal than pitavastatin or ezetimibe alone for hypercholesterolemia treatment. Furthermore, 1PC111 may provide more benefit in treating elderly patients.CLINICALTRIALSgov identifier: NCT04643093.

100 Deals associated with 1PC111

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hyperlipidemia, Familial Combined	Phase 3	TW	Orient Pharma Co., Ltd.	01 Aug 2020
Hyperlipidemia, Familial Combined	Phase 3	AU	Orient Pharma Co., Ltd.	01 Aug 2020
Hyperlipidemia, Familial Combined	Phase 3	NZ	Orient Pharma Co., Ltd.	01 Aug 2020
Primary hypercholesterolemia	Phase 3	AU	Orient Pharma Co., Ltd.	01 Aug 2020
Primary hypercholesterolemia	Phase 3	NZ	Orient Pharma Co., Ltd.	01 Aug 2020
Primary hypercholesterolemia	Phase 3	TW	Orient Pharma Co., Ltd.	01 Aug 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

1PC111

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation