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
| Tracking Information | |||||
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| First Received Date ICMJE | April 2, 2008 | ||||
| Last Updated Date | December 17, 2012 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
urinary albumin excretion or proteinuria at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00655330 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy | ||||
| Official Title ICMJE | A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy | ||||
| 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. |
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| Detailed Description | a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 170 | ||||
| Estimated Completion Date | May 2016 | ||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00655330 | ||||
| Other Study ID Numbers ICMJE | GPPH200603 -1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Wei Shi, Guangdong General Hospital | ||||
| Study Sponsor ICMJE | Guangdong General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Guangdong General Hospital | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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