Status:
COMPLETED
A Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy
Lead Sponsor:
Otsuka Beijing Research Institute
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief 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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT01252056
Start Date
March 1 2010
End Date
December 1 2012
Last Update
May 8 2013
Active Locations (1)
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1
Beijing Universuty First Hospital
Beijng, Beijing Municipality, China