This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, nephropathy
Treatments valsartan, placebo, probucol
Sponsor Guangdong General Hospital
Start date May 2008
End date May 2017
Trial size 170 participants
Trial identifier NCT00655330, GPPH200603 -1


This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Valsartan (160mg/day)is given in combination with Placebo
Valsartan (160mg/day)
Valsartan (160mg/day) + Probucol (750mg/day)
Valsartan (160mg/day)
Probucol (750mg/day)

Primary Outcomes

urinary albumin excretion or proteinuria at week 48
time frame: 48 weeks

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

Inclusion Criteria: - Type 2 Diabetes nephropathy - Urinary albumin excretion 1-3g/24hours - Serum creatinine < 3mg/dl Exclusion Criteria: - Type 1 diabetes mellitus - Renal diseases other than type 2 Diabetes nephropathy - Renal artery stenosis - Severe heart diseases - Tuberculosis

Additional Information

Official title A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy
Principal investigator Shi Wei, MD, PhD
Description a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy - Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day) - Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Guangdong General Hospital.