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A Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy

Information source: Otsuka Beijing Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Nephropathy

Intervention: Probucol (Drug); Probucol and Cilostazol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Otsuka Beijing Research Institute

Official(s) and/or principal investigator(s):
Xiaohui Guo, Principal Investigator, Affiliation: Beijing University First Hospital

Summary

The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic nephropathy is better than the single use.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: nephropathy development

Secondary outcome:

IMT

Atherosclerosis related biomarkers

Nephropathy development

Adverse events

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.

Eligibility

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female age 40~75 years old

- Type 2 diabetes mellitus above 6 months

- HbA1c ≤8%

- Twice (above 2-week interval) confirmed urinary albumin at 30-3000µg/mg. cre

- Receive routine dosage ACEI or ARB treatment above 2 months, and the dosage has been

fixed for at least 1 month

- LDL-C>100 mg/dL (2. 60 mmol/L) and/ or hyperlipidemia patients with Statins treatment

- Free will to sign the informed consent form

Exclusion Criteria:

- Has an allergic history to investigational drugs

- Receive antilipemic agents (except Statins) within the latest 2 months, including

Probucol

- Receive antiplatelet or anticoagulation agents (except Aspirin) within the latest 2

months, including Cilostazol

- Rapid progression of nephropathy within the latest 3 months

- Kidney disease caused by other reasons according to medical history

- Serum potassium level less than 3. 5 mEq/L or more than 5. 5 mEq/L

- Hemorrhagic tendency or hemorrhagic disease (such as alimentary tract hemorrhage,

active fundus hemorrhage, etc.)

- Has a myocardial infarction, angina pectoris, or cerebral infarction within the

latest 3 months

- Congestive heart failure

- Pregnant, potentially pregnant, or lactating woman

- Severe hepatic inadequacy (AST or ALT is 2. 5 times higher than the upper limit of the

normal value range)

- Serum creatinine level is 1. 5 times higher than the upper limit of the normal value

range

- Persistent or hardly controlled hypertension (such as malignant hypertension, SBP≥170

mmHg and/ or DBP≥100 mmHg)

- Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular

contractions)

- Has a medical history of cardiac syncope or primary syncope

- Has condition that may prolong QT interval (such as congenital long QT syndrome,

taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.), or for man QT interval>450msec, for woman QT interval>470msec

- Has severe complication (such as diabetes mellitus ketoacidosis, nonketotic

hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)

- Register other clinical trials within the latest 3 months

- Other conditions that would be excluded from this study according to doctors'judgment

Locations and Contacts

Beijing Universuty First Hospital, Beijng, Beijing, China
Additional Information

Starting date: March 2010
Last updated: May 7, 2013

Page last updated: August 23, 2015

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