NCT00655330

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

9 years

First QC Date

April 2, 2008

Last Update Submit

August 23, 2016

Conditions

Type 2 Diabetes MellitusNephropathy

Keywords

Type 2 diabetes mellitusNephropathyvalsartanprobucolProteinuria

Outcome Measures

Primary Outcomes (1)

  • urinary albumin excretion or proteinuria at week 48

    48 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: ValsartanDrug: Placebo

2

EXPERIMENTAL

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

Drug: ValsartanDrug: Probucol

Interventions

ValsartanDRUG

Valsartan (160mg/day)

12
PlaceboDRUG

Placebo

1
ProbucolDRUG

Probucol (750mg/day)

2

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes nephropathy
  • Urinary albumin excretion 1-3g/24hours
  • Serum creatinine \< 3mg/dl

You may not qualify if:

  • Type 1 diabetes mellitus
  • Renal diseases other than type 2 Diabetes nephropathy
  • Renal artery stenosis
  • Severe heart diseases
  • Tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Kidney DiseasesProteinuria

Interventions

ValsartanProbucol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Shi Wei, MD, PhD

    Nephrology Dept.,Guangdong General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of renal division of Guangdong General Hospital

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 9, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

CN(1)