NCT01726816

Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

A Phase II, Multicenter, Randomized, Double Blind, Double-dummy, 16-week, Placebo Controlled Study to Evaluate the Efficacy and Safety of Probucol in Patients With Nephropathy Due to Type 2 Diabetes.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

1. Usage: 16 week, BID, Prescribed Oral with the breakfast and dinner 2. Dosage:Placebo group: placebo 2 tablets, 16 weeks Probucol 250mg group: probucol 125mg 2 tablets, 16 weeks Probucol 500mg group: probucol 250 mg 2 tablets, 16 weeks

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Probucol 250mg/day	Probucol 250mg + Placebo
DRUG	Probucol 500mg/day	Probucol 500mg + Placebo
DRUG	Placebo	Probucol matching placebo

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-04-01
• Completion: 2014-09-01
• First posted: 2012-11-15
• Last updated: 2017-05-03

Locations

16 sites across 1 country: South Korea