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Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

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ClinicalTrials.gov Identifier: NCT00655330
Recruitment Status : Unknown
Verified August 2016 by Wei Shi, Guangdong General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 9, 2008
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2008
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Valsartan

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)




Primary Outcome Measures :
  1. urinary albumin excretion or proteinuria at week 48 [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655330


Locations
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China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong General Hospital
Investigators
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Principal Investigator: Shi Wei, MD, PhD Nephrology Dept.,Guangdong General Hospital

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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
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by Wei Shi, Guangdong General Hospital:
Type 2 diabetes mellitus
Nephropathy
valsartan
probucol
Proteinuria
Additional relevant MeSH terms:
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Kidney Diseases
Proteinuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Valsartan
Probucol
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs