NCT00823875CompletedPhase 4
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
Otsuka Beijing Research Institute1 site in 1 country200 target enrollmentStarted: March 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Study Overview
Brief 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 .
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •40～80-year-old male or female
- •By brain CT or MRI result, cerebral infarction is clarified diagnosis within 1 year
- •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
- •Has Aspirin regularly for more than 1 month before registration
- •Informed Consent Form signature
- •Exclusion criteria：
- •Has an allergic history to study drugs( including of Probucol and Cilostazol) and Aspirin
- •Had lipid-lowing agents within the last 3 months ( except Statins)
- •Had antiplatelet or anticoagulation agents within the last 3 months (except Aspirin)
- •Had acute cerebral infarction within the last 1 month
- •Has cardiogenic cerebral embolism
- •At the registration ,Modified Rankin Scale ≥ 4
- •Hemorrhagic tendency or hemorrhagic disease (such as cerebral hemorrhage, gastrointestinal tract hemorrhage, etc.)
- •Had a myocardial infarction, angina pectoris within the last 3 months
- •Congestive heart failure
- •Is pregnant, is potentially pregnant, or is breastfeeding
- •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)
- •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 a condition that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
- •Has severe diseases (such as, malignant tumor, severe anaemia, severe hematologic diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, etc.)
- •Registered other clinical trails within the last 3 months
- •Has vasculitis, moyamoya disease and other non-atherosclerosis vascular diseases
- •Other conditions that could exclude the subject from this study by doctor's judgment
Exclusion Criteria
- Not provided
Arms & Interventions
1
Experimental
Intervention: Cilostazol group (Drug)
2
Experimental
Intervention: Probucol group (Drug)
3
Experimental
Intervention: Cilostazol + Probucol group (Drug)
4
Other
Control Group
Intervention: control group (Drug)
Outcomes
Primary Outcomes
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Time Frame: 12 week
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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