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NCT00655330 Clinical Trial

Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

Type 2 Diabetes Mellitus Clinical Trial

Official title:
A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00655330
Other study ID # GPPH200603 -1
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 2, 2008
Last updated August 23, 2016
Start date May 2008
Est. completion date May 2017

Study information
Verified date August 2016
Source Guangdong General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 170
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Valsartan
Valsartan (160mg/day)
• Placebo
Placebo
• Probucol
Probucol (750mg/day)

Locations
Country Name City State
China Guangdong General Hospital Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary urinary albumin excretion or proteinuria at week 48 48 weeks No
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