Probucol Combined With Valsartan in Reducing Proteinuria... | NCT00655330

Studies
Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

NCT00655330

Sponsor

Guangdong Provincial People's Hospital

Status

Unknown status

Last Update Posted

Aug 24, 2016Estimated

Enrollment

170Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus
Nephropathy

Interventions

Valsartan
Placebo
Probucol

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2017Estimated

Completion Date

May 2017Estimated

First Submitted Date

Apr 2, 2008

First Submission Date that Met QC Criteria

Apr 8, 2008

First Posted Date

Apr 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2016

Last Update Posted Date

Aug 24, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong Provincial People's HospitalPrincipal Investigator

Lead Sponsor

Guangdong Provincial People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Valsartan (160mg/day)is given in combination with Placebo	Drug: Valsartan Drug: Placebo
2	Experimental	Valsartan (160mg/day) + Probucol (750mg/day)	Drug: Valsartan Drug: Probucol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valsartan	Drug	Valsartan (160mg/day)	1 2
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong General Hospital		Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D007674	Kidney Diseases
D011507	Proteinuria

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068756	Valsartan
D011341	Probucol

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided