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
Verified date | August 2016 |
Source | Guangdong General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Guangdong General Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | urinary albumin excretion or proteinuria at week 48 | 48 weeks | No |
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