A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia

Summary

The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.

Timeline

Start

2015-11

Primary completion

2018-01

Completion

2018-05

Outcome

Met primary endpoint

paper between the combination therapy and monotherapy groups was -12.45% (95% CI, -17.18 to -7.72) PMID 32891418 ↗

paper the combination therapy was associated with a greater reduction in non-HDL-C. PMID 32891418 ↗

Publications

• Ihm SH, Chung WB, Lee JM, Hwang BH, Yoo KD, Her SH, Song WH, Chae IH, Park TH, Kim JH, Jeon DW, Cho BR, Kang SH, Park SD, Lee JB, Woo JT, Lee BW, Han KA, Won KH, Kim HS, Yu JM, Chung CH, Kim HJ, Cho HC, Seung KB. Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial. Clin Ther. 2020 Oct;42(10):2021-2035.e3. doi: 10.1016/j.clinthera.2020.08.002. Epub 2020 Sep 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fenofibrate	Small molecule	160 mg	—
Comparator	Pitavastatin	Small molecule	2 mg	—

Indications