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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Beijing Research Institute
• Treatments: Cilostazol; Probucol

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