Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy
Not Applicable
- Conditions
- Type 2 Diabetes MellitusNephropathy
- Interventions
- Registration Number
- NCT00655330
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
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.
- Detailed 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 170
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Valsartan (160mg/day)is given in combination with Placebo 1 Valsartan Valsartan (160mg/day)is given in combination with Placebo 2 Valsartan Valsartan (160mg/day) + Probucol (750mg/day) 2 Probucol Valsartan (160mg/day) + Probucol (750mg/day)
- Primary Outcome Measures
Name Time Method urinary albumin excretion or proteinuria at week 48 48 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China