Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

Phase 2 Completed 126 enrolled Korea Otsuka Pharmaceutical Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial. * Screening period (4 week) * Double blind treatment period (16 weeks)

Timeline

Start: 2012-10
Primary completion: 2014-04
Completion: 2014-09

Outcome

Missed primary endpoint

paper P=0.2077 versus placebo group PMID 27493100 ↗

paper Four months of probucol up to 500 mg/d failed to reduce urinary albumin excretion. PMID 27493100 ↗

Publications

Jin SM, Han KA, Yu JM, Sohn TS, Choi SH, Chung CH, Park IeB, Rhee EJ, Baik SH, Park TS, Lee IK, Ko SH, Hwang YC, Cha BS, Lee HW, Nam MS, Lee MK. Probucol in Albuminuric Type 2 Diabetes Mellitus Patients on Renin-Angiotensin System Blockade: A 16-Week, Randomized, Double-Blind, Placebo-Controlled Trial. Arterioscler Thromb Vasc Biol. 2016 Oct;36(10):2108-14. doi: 10.1161/ATVBAHA.116.308034. Epub 2016 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Probucol	Small molecule	250 mg	Oral
Subject	Probucol	Small molecule	500 mg	Oral