Trials / Completed
CompletedNCT01252056
A Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy
A Randomized, Control, Parallel, Open Label, Multi-centre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 353 (actual)
- Sponsor
- Otsuka Beijing Research Institute · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic nephropathy is better than the single use.
Detailed description
The objectives of this study is: 1. To evaluate the efficacy of Probucol on deferring nephropathy development of the patients with diabetic nephropathy (including: the change value of urine albumin from the baseline, the rate of the patients with serum creatinine reaching a doubling of the base-line serum creatinine, the rate of the hemodialysis-free survival). 2. To evaluate the efficacy of Cliostazol and Probucol in combination on deferring nephropathy development of the patients with diabetic nephropathy 3. To evaluate the efficacy of Cilostazol and Probucol in combination on atherosclerosis related biomarkers change. Atherosclerosis related biomarkers include:(a)Endothelium parameter: ICAM-1, vWF, VCAM-1,and McP-1. (b)Finolysis parameter: TM. (c)Inflammation parameter: Hs-CRP; IL-6. (d)Oxidation parameter: Ox-LDL, 8-OHdG. (e)Lipid parameter: TC, LDL-C, HDL-C, TG. 4. To evaluate the efficacy of Cilostazol and Probucol in combination on the progress of carotid intima-media thickness (IMT) on patients with diabetic nephropathy. 5. To evaluate the safety of Cilostazol and Probucol in combination on the patients with diabetic nephropathy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Probucol | 250mg,Bid |
| DRUG | Probucol and Cilostazol | 50-100mg,Bid |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2010-12-02
- Last updated
- 2013-05-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01252056. Inclusion in this directory is not an endorsement.