Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy
This study is currently recruiting participants.
Verified December 2012 by Guangdong General Hospital
Sponsor:
Guangdong General Hospital
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT00655330
First received: April 2, 2008
Last updated: December 17, 2012
Last verified: December 2012
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Purpose
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 | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus Nephropathy |
Drug: Valsartan Drug: Placebo Drug: Probucol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Guangdong General Hospital:
Primary Outcome Measures:
- urinary albumin excretion or proteinuria at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 170 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655330
Contacts
| Contact: Shi Wei, MD, PhD | (86-20)83850849 | weishi_gz@126.com |
Locations
| China, Guangdong | |
| Guangdong General Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510080 | |
| Contact: wei shi, MD,PhD 86-20-8385-0849 weishi_gz@126.com | |
Sponsors and Collaborators
Guangdong General Hospital
Investigators
| Principal Investigator: | Shi Wei, MD, PhD | Nephrology Dept.,Guangdong General Hospital |
More Information
No publications provided
| Responsible Party: | Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong General Hospital |
| ClinicalTrials.gov Identifier: | NCT00655330 History of Changes |
| Other Study ID Numbers: | GPPH200603 -1 |
| Study First Received: | April 2, 2008 |
| Last Updated: | December 17, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Guangdong General Hospital:
|
Type 2 diabetes mellitus Nephropathy valsartan probucol Proteinuria |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Kidney Diseases Proteinuria Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Urination Disorders Urological Manifestations Signs and Symptoms Probucol Valsartan Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Antioxidants Protective Agents Physiological Effects of Drugs Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Antihypertensive Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013