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Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Guangdong General Hospital
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT00655330
First received: April 2, 2008
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy

Resource links provided by NLM:


Further study details as provided by Guangdong General 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 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Valsartan (160mg/day)is given in combination with Placebo
Drug: Valsartan
Valsartan (160mg/day)
Drug: Placebo
Placebo
Experimental: 2
Valsartan (160mg/day) + Probucol (750mg/day)
Drug: Valsartan
Valsartan (160mg/day)
Drug: Probucol
Probucol (750mg/day)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: wei shi, MD,PhD    86-20-8385-0849    weishi_gz@126.com   
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Shi Wei, MD, PhD Nephrology Dept.,Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT00655330     History of Changes
Other Study ID Numbers: GPPH200603 -1
Study First Received: April 2, 2008
Last Updated: August 27, 2013
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
Type 2 diabetes mellitus
Nephropathy
valsartan
probucol
Proteinuria

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Probucol
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Antioxidants
Cardiovascular Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014