Diabetic Nephropathy Clinical Trial
Official title:
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
The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic nephropathy is better than the single use.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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