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

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Atherosclerosis

Drug Information available for: 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
Study Completion Date:	July 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	Quanjie Wei, Otsuka Beijing Research Institue
ClinicalTrials.gov Identifier:	NCT00823875 History of Changes
Other Study ID Numbers:	260-08-803-01
Study First Received:	January 15, 2009
Last Updated:	November 30, 2010
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:


Arteriosclerosis Atherosclerosis Cerebral Infarction Infarction Intracranial Arteriosclerosis Stroke Arterial Occlusive Diseases Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Ischemia	Necrosis Nervous System Diseases Pathologic Processes Vascular Diseases Cilostazol Probucol Anti-Asthmatic Agents Anticholesteremic Agents Antimetabolites Antioxidants Autonomic Agents Bronchodilator Agents Cardiovascular Agents Central Nervous System Agents Enzyme Inhibitors

ClinicalTrials.gov processed this record on March 03, 2015