Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

August 23, 2016 updated by: Wei Shi, Guangdong Provincial People's Hospital

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Valsartan (160mg/day)is given in combination with Placebo
Drug: Placebo
Placebo
Drug: Valsartan
Valsartan (160mg/day)
Experimental: 2
Valsartan (160mg/day) + Probucol (750mg/day)
Drug: Probucol
Probucol (750mg/day)
Drug: Valsartan
Valsartan (160mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urinary albumin excretion or proteinuria at week 48
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPPH200603 -1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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