Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker

Official Title: “A Randomized, Control,Open Label, Multicentre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker”

1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker

2. To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker

Efficacy evaluation:

Primary efficacy index:

After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information

Secondary efficacy index:

After 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information

Safety evaluation:

1. Adverse Event

2. Vital Sign and Physical Examination

3. 12-lead ECG

4. Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)

Intervention(s) in this Clinical Trial

• Drug: Cilostazol
  • From 50mg, Bid, PO after breakfast and dinner. After 1-week of administration, if no significant study drug related discomfort, the dose can increase to 100mg, Bid, PO. Otherwise, remain at the 50 mg level.
• Drug: Probucol
  • 250 mg Bid, PO after breakfast and dinner.
• Drug: Cilostazol+Probucol
  • TBD
• Other: Control Group
  • Routine treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• No Intervention: 4
  • Control Group

Primary Measures

• Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment.
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• 40~75-year-old male or female
• Clarified diagnosis of type 2 diabetes mellitus
• Arteriosclerosis obliterans (ASO) is diagnosed (ASO diagnoses should meet at least one of the conditions as below:
• ABI<1.0;
• The pulse of popliteal artery or dorsalis pedis artery is weeken significantly or is different between left and right sides
• Intermittent claudication, diagnosed as ASO by doctor
• Ultrasonogram showed that there was atherosclerotic plaque in lower limb within 1 year
• Informed Consent Form Signature

Exclusion Criteria:

• Has an allergic history to study drugs
• Use one of the following drugs: other antiplatelet or anticoagulation agents except
• Aspirin, other hypolipidemic agents except Statins
• Type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetes mellitus
• Has severe ASO above Fontaine IIb,
• Hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tract hemorrhage, etc.)
• Had a myocardial infarction, angina pectoris, or cerebral infarction within the last 3 months
• Congestive heart failure
• Is pregnant, or potentially pregnant, or breastfeeding
• Severe hepatic insufficient or severe renal insufficiency (AST or ALT is 2.5 times higher than the upper limit of the normal value range, or serum creatinine is 1.2 times higher than the upper limit of the normal value range)
• Persistent or hardly controlled hypertension (such as malignant hypertension, BP>
• 160/100 mmHg)
• Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
• Has a medical history that includes a cardiac syncope or a primary syncope
• Has conditions that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
• Has severe complications (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)
• Other conditions that would exclude the subject from this study by doctor's judgement

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Otsuka Beijing Research Institute Industry

Overall Clinical Trial Officials and Contacts

Xiaohui Guo, M.D. Principal Investigator No 1 Hospital of Peking University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00823849

Study ID Number: 246-08-802-01

ClinicalTrials.gov Identifier: NCT00823849

Health Authority: China: State Food and Drug Administration