Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

• Sponsor: Guangdong Provincial People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00655330
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Arms: 2
• Duration (Months): 108
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus; Nephropathy	Drug: Valsartan; Drug: Placebo; Drug: Probucol	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy
• Study Start Date: May 1, 2008
• Anticipated Primary Completion Date: May 1, 2017
• Anticipated Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Valsartan (160mg/day)is given in combination with Placebo	Drug: Valsartan; Valsartan (160mg/day); Drug: Placebo; Placebo
Experimental: 2 Valsartan (160mg/day) + Probucol (750mg/day)	Drug: Valsartan; Valsartan (160mg/day); Drug: Probucol; Probucol (750mg/day)

Outcome Measures

Primary Outcome Measures

1. urinary albumin excretion or proteinuria at week 48 [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong General Hospital	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Guangdong Provincial People's Hospital

Investigators

• Principal Investigator: Shi Wei, MD, PhD, Nephrology Dept.,Guangdong General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT00655330
• Other Study ID Numbers: GPPH200603 -1
• First Posted: Apr 9, 2008
• Last Update Posted: Aug 24, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong Provincial People's Hospital: Type 2 diabetes mellitus; Nephropathy; valsartan; probucol; Proteinuria
• Additional relevant MeSH terms: Kidney Diseases; Proteinuria; Diabetes Mellitus; Diabetes Mellitus, Type 2; Valsartan; Probucol

Study Results

No Results Posted as of Aug 24, 2016