Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

This study is currently recruiting participants.

Verified by Guangdong Provincial People's Hospital, February 2009

First Received: April 2, 2008 Last Updated: February 2, 2009 History of Changes

Sponsored by:	Guangdong Provincial People's Hospital
Information provided by:	Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier:	NCT00655330

Purpose

This is a prospective randomized controlled, double blinded 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.

Condition	Intervention
Type 2 Diabetes Mellitus Nephropathy	Drug: Valsartan Drug: Placebo Drug: Probucol

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective Randomized, Controlled, Double Blinded Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Probucol Valsartan

U.S. FDA Resources

Further study details as provided by Guangdong Provincial People's Hospital:

Primary Outcome Measures:

urinary albumin excretion or proteinuria at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	170
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Valsartan (160mg/day) + Placebo	Drug: Valsartan Valsartan (160mg/day) Drug: Placebo Placebo
2: Experimental Valsartan (160mg/day) + Probucol (750mg/day)	Drug: Valsartan Valsartan (160mg/day) Drug: Probucol Probucol (750mg/day)

Detailed Description:

a prospective randomized controlled, double blinded 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

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655330

Contacts

Contact: Shi Wei, MD, PhD

(86-20)83850849

weishi_gz@126.com

Locations

China, Guangdong
Guangdong Provincial People's Hospital	Recruiting
Guangzhou, Guangdong, China, 510080
Contact: wei shi, MD,PhD 86-20-8385-0849 weishi_gz@126.com

Sponsors and Collaborators

Guangdong Provincial People's Hospital

Investigators

Principal Investigator:

Shi Wei, MD, PhD

Nephrology Dept.,Guangdong Provincial People's Hospital

More Information

No publications provided

Responsible Party:	Guangdong Provincial People's Hospital ( Wei Shi )
Study ID Numbers:	GPPH200603 -1, No
Study First Received:	April 2, 2008
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00655330 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Guangdong Provincial People's Hospital:

Type 2 diabetes mellitus
Nephropathy
valsartan
probucol
Proteinuria

Study placed in the following topic categories:

Antimetabolites
Antioxidants
Metabolic Diseases
Probucol
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Anticholesteremic Agents

Antihypertensive Agents
Proteinuria
Urologic Diseases
Diabetes Mellitus, Type 2
Kidney Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Valsartan

Additional relevant MeSH terms:

Antimetabolites
Antioxidants
Metabolic Diseases
Probucol
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents

Anticholesteremic Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Urologic Diseases
Therapeutic Uses
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Valsartan

ClinicalTrials.gov processed this record on September 09, 2009