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

Sponsor:	Otsuka Beijing Research Institute
Information provided by:	Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:	NCT00823875

Purpose

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 .

Condition	Intervention	Phase
Atherosclerosis Cerebral Infarction	Drug: Cilostazol group Drug: Probucol group Drug: Cilostazol + Probucol group Drug: control group	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Probucol Cilostazol

U.S. FDA Resources

Further study details as provided by Otsuka Beijing Research Institute:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Experimental	Drug: Probucol group Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
3: Experimental	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
4 Control Group	Drug: control group routine treatment

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

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823875

Locations

China
First Affliate Hospital of Beijing University
Beijing, China

Sponsors and Collaborators

Otsuka Beijing Research Institute

Investigators

Principal Investigator:

Yining Huang, M.D.

Peking University First Hospital

More Information

No publications provided

Responsible Party:	Otsuka Beijing Research Institue ( Quanjie Wei )
Study ID Numbers:	260-08-803-01
Study First Received:	January 15, 2009
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00823875 History of Changes
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Atherosclerosis
Antimetabolites
Respiratory System Agents
Vasodilator Agents
Antioxidants
Cerebral Infarction
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Arteriosclerosis
Brain Diseases
Neuroprotective Agents
Cerebrovascular Disorders
Intracranial Arterial Diseases

Intracranial Arteriosclerosis
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Cilostazol
Probucol
Antilipemic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on February 08, 2010