Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

Verified by: Guangdong General Hospital, December 2011
First Received: April 2, 2008 | Last Updated: December 29, 2011 | Phase: N/A | Start Date: May 2008
Overall Status: Recruiting | Estimated Enrollment: 170
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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...

Brief Summary

Official Title: “A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy”

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.

  • 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
  • Study Primary Completion Date: May 2013

Detailed Clinical Trial 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

Intervention(s) in this Clinical Trial

  • Drug: Valsartan
    • Valsartan (160mg/day)
  • Drug: Placebo
    • Placebo
  • Drug: Probucol
    • Probucol (750mg/day)

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Valsartan (160mg/day)is given in combination with Placebo
  • Experimental: 2
    • Valsartan (160mg/day) + Probucol (750mg/day)

Outcome Measures for this Clinical Trial

Primary Measures

  • urinary albumin excretion or proteinuria at week 48
    • Time Frame: 48 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Guangdong General Hospital Other

Overall Clinical Trial Officials and Contacts

Shi Wei, MD, PhD Principal Investigator Nephrology Dept.,Guangdong General Hospital  

Overall Contact: Shi Wei, MD, PhD (86-20)83850849 weishi_gz@126.com

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655330

Study ID Number: GPPH200603 -1

ClinicalTrials.gov Identifier: NCT00655330

Health Authority: China: Ethics Committee

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00655330