Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy
Information source: Guangdong General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Nephropathy
Intervention: Valsartan (Drug); Placebo (Drug); Probucol (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Guangdong General Hospital Official(s) and/or principal investigator(s):
Shi Wei, MD, PhD, Principal Investigator, Affiliation: Nephrology Dept.,Guangdong General Hospital
Overall contact:
Shi Wei, MD, PhD, Phone: (86-20)83850849, Email: weishi_gz@126.com
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.
Clinical Details
Official title: A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: urinary albumin excretion or proteinuria at week 48
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
Eligibility
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Shi Wei, MD, PhD, Phone: (86-20)83850849, Email: weishi_gz@126.com
Guangdong General Hospital, Guangzhou, Guangdong 510080, China; Recruiting
wei shi, MD,PhD, Phone: 86-20-8385-0849, Email: weishi_gz@126.com
Additional Information
Starting date: May 2008
Last updated: August 17, 2015
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