Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

NCT ID: NCT00655330

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

Valsartan (160mg/day)

Placebo

Intervention Type DRUG

Placebo

2

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

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan (160mg/day)

Probucol

Intervention Type DRUG

Probucol (750mg/day)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valsartan

Valsartan (160mg/day)

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Probucol

Probucol (750mg/day)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wei Shi

Director of renal division of Guangdong General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shi Wei, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nephrology Dept.,Guangdong General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GPPH200603 -1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Colchicine for Diabetic Nephropathy
NCT01005121 UNKNOWN PHASE2
Statins in Proteinuric Nephropathies
NCT00199927 COMPLETED PHASE3
Enhancing the Natriuretic Peptide System in HFpEF
NCT05279742 ENROLLING_BY_INVITATION PHASE1/PHASE2
VA NEPHRON-D: Diabetes iN Nephropathy Study
NCT00555217 TERMINATED PHASE3