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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

Page last updated: August 20, 2015

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