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Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

Primary Purpose

Type 2 Diabetes Mellitus, Nephropathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Valsartan
Placebo
Probucol
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, Nephropathy, valsartan, probucol, Proteinuria

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Valsartan (160mg/day)is given in combination with Placebo

Valsartan (160mg/day) + Probucol (750mg/day)

Outcomes

Primary Outcome Measures

urinary albumin excretion or proteinuria at week 48

Secondary Outcome Measures

Full Information

First Posted
April 2, 2008
Last Updated
August 23, 2016
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00655330
Brief Title
Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy
Official Title
A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Nephropathy
Keywords
Type 2 diabetes mellitus, Nephropathy, valsartan, probucol, Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Valsartan (160mg/day)is given in combination with Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Valsartan (160mg/day) + Probucol (750mg/day)
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Description
Valsartan (160mg/day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Probucol
Intervention Description
Probucol (750mg/day)
Primary Outcome Measure Information:
Title
urinary albumin excretion or proteinuria at week 48
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Wei, MD, PhD
Organizational Affiliation
Nephrology Dept.,Guangdong General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

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