This is a prospective randomized controlled, double blinded 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...
Date First Received: April 2, 2008
Last Updated: February 2, 2009
Verified by: Guangdong Provincial People's Hospital, February 2009
Clinical Trial Phase: N/A | Start Date: May 2008
Overall Status: Recruiting
Estimated Enrollment: 170
Brief Summary
Official Title: “A Prospective Randomized, Controlled, Double Blinded Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy”
Condition Keyword(s):
Intervention(s):
This is a prospective randomized controlled, double blinded 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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: May 2009
Detailed Clinical Trial Description
a prospective randomized controlled, double blinded study in patients with Diabetes nephropathy - Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day) - Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo
Intervention(s) in this Clinical Trial
- Drug: Valsartan
- Valsartan (160mg/day)
- Drug: Placebo
- Placebo
- Drug: Probucol
- Probucol (750mg/day)
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Valsartan (160mg/day) + Placebo
- Experimental: 2
- Valsartan (160mg/day) + Probucol (750mg/day)
Outcome Measures for this Clinical Trial
Primary Measures
- urinary albumin excretion or proteinuria at week 48
- Time Frame: 48 weeks
Safety Issue?: No
- Time Frame: 48 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Guangdong Provincial People's Hospital
Overall Clinical Trial Officials and Contacts
Shi Wei, MD, PhD Principal Investigator Nephrology Dept.,Guangdong Provincial People's Hospital
Overall Contact: Shi Wei, MD, PhD (86-20)83850849 weishi_gz@126.com
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655330
Study ID Number: GPPH200603 -1
ClinicalTrials.gov Identifier: NCT00655330
Health Authority: China: Ethics Committee
Clinical Trials Authorship and Review
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