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Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655330
First Posted: April 9, 2008
Last Update Posted: August 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
  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
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

Resource links provided by NLM:


Further study details as provided by Wei Shi, Guangdong General Hospital:

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

Estimated Enrollment: 170
Study Start Date: May 2008
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Shi Wei, MD, PhD Nephrology Dept.,Guangdong General Hospital
  More Information

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 Submitted: April 2, 2008
First Posted: April 9, 2008
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:
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
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