Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject

This study has been completed.
Sponsor:
Information provided by:
Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:
NCT00823875
First received: January 15, 2009
Last updated: November 30, 2010
Last verified: January 2010

January 15, 2009
November 30, 2010
March 2009
December 2009   (final data collection date for primary outcome measure)
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups. [ Time Frame: 12 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00823875 on ClinicalTrials.gov Archive Site
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Not Provided
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Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject
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

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 .

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atherosclerosis Cerebral Infarction
  • Drug: Cilostazol group
    Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg(2 tablets)Bid.
    Other Name: Pletaal
  • Drug: Probucol group
    Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
    Other Name: Changtai
  • Drug: Cilostazol + Probucol group

    Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg(2 tablets)Bid.

    Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner

    Other Name: Pletaal and Changtai
  • Drug: control group
    routine treatment
    Other Name: Routine Treatment
  • Experimental: 1
    Intervention: Drug: Cilostazol group
  • Experimental: 2
    Intervention: Drug: Probucol group
  • Experimental: 3
    Intervention: Drug: Cilostazol + Probucol group
  • 4
    Control Group
    Intervention: Drug: control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00823875
260-08-803-01
No
Quanjie Wei, Otsuka Beijing Research Institue
Otsuka Beijing Research Institute
Not Provided
Principal Investigator: Yining Huang, M.D. Peking University First Hospital
Otsuka Beijing Research Institute
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP