Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject
Information source: Otsuka Beijing Research Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atherosclerosis Cerebral Infarction
Intervention: Cilostazol group (Drug); Probucol group (Drug); Cilostazol + Probucol group (Drug); control group (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Otsuka Beijing Research Institute Official(s) and/or principal investigator(s):
Yining Huang, M.D., Principal Investigator, Affiliation: Peking University First Hospital
Overall contact:
Quanjie Wei, Phone: 85182966, Ext: 8013, Email: weiqj@obri.otsuka.com
Summary
Randomized, control, open label, multicentre clinical study. The patient who are in
accordance with subject inclusion and exclusion criteria will be randomized to A group:
Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment +
Probucol; D group: Routine treatment+ Cilostazol+ Probucol .
Clinical Details
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---atherosclerosis Cerebral Infarction Patient as Study Subject
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Detailed description:
Efficacy index:
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker
between 4 modality groups.
Pharmacokinetics:
After 12 weeks of treatment, the study medication plasma concentration including of Probucol
,Cilostazol , Cilostazol metabolism OPC-13015 and OPC-13213 will be measured.
Safety evaluation:
Analysis the abnormality of Adverse Event, Vital Sign, Physical Examination, 12-lead ECG,
and Laboratory Tests (including blood routine examination, routine urine analysis, blood
biochemistry examination, glycosylated hemoglobin) in 4 modality groups.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 40～80-year-old male or female
2. By brain CT or MRI result, cerebral infarction is clarified diagnosis within 1 year
3. With atherosclerosis, atherosclerosis should meet at least one of the conditions as
below:
- Clarified diagnosis of type 2 diabetes before
- Clarified diagnosis of primary hypertension before
- Clarified diagnosis of Atherosclerotic stenosis in any 2 or more than 2 regions
as cerebral artery, carotid, extremity artery and coronary by conformation of
ultrasonic or angiography result
4. Has Aspirin regularly for more than 1 month before registration
5. Informed Consent Form signature
Exclusion criteria：
1. Has an allergic history to study drugs( including of Probucol and Cilostazol) and
Aspirin
2. Had lipid-lowing agents within the last 3 months ( except Statins)
3. Had antiplatelet or anticoagulation agents within the last 3 months (except Aspirin)
4. Had acute cerebral infarction within the last 1 month
5. Has cardiogenic cerebral embolism
6. At the registration ,Modified Rankin Scale ≥ 4
7. Hemorrhagic tendency or hemorrhagic disease (such as cerebral hemorrhage,
gastrointestinal tract hemorrhage, etc.)
8. Had a myocardial infarction, angina pectoris within the last 3 months
9. Congestive heart failure
10. Is pregnant, is potentially pregnant, or is breastfeeding
11. Severe hepatic inadequacy or severe renal inadequacy (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)
12. Persistent or hardly controlled hypertension (such as malignant hypertension, BP>
160/100 mmHg)
13. Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular
contractions)
14. Has a medical history that includes a cardiac syncope or a primary syncope
15. Has a condition that may prolong QT interval (such as congenital long QT syndrome,
taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
16. Has severe diseases (such as, malignant tumor, severe anaemia, severe hematologic
diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, etc.)
17. Registered other clinical trails within the last 3 months
18. Has vasculitis, moyamoya disease and other non-atherosclerosis vascular diseases
19. Other conditions that could exclude the subject from this study by doctor's judgment
Locations and Contacts
Quanjie Wei, Phone: 85182966, Ext: 8013, Email: weiqj@obri.otsuka.com
First Affliate Hospital of Beijing University, Beijing, China; Recruiting
Yining Huang, M.D.
Additional Information
Starting date: March 2009
Ending date: September 2009
Last updated: August 25, 2009
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