Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker
NCT ID: NCT00823849
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2008-10-31
2010-03-31
Brief Summary
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2. To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
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Detailed Description
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Primary efficacy index:
After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information
Secondary efficacy index:
After 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information
Safety evaluation:
1. Adverse Event
2. Vital Sign and Physical Examination
3. 12-lead ECG
4. Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Cilostazol
From 50mg, Bid, PO after breakfast and dinner. After 1-week of administration, if no significant study drug related discomfort, the dose can increase to 100mg, Bid, PO. Otherwise, remain at the 50 mg level.
2
Probucol
250 mg Bid, PO after breakfast and dinner.
3
Cilostazol+Probucol
4
Control Group, regular treatment
Control Group
Routine treatment
Interventions
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Cilostazol
From 50mg, Bid, PO after breakfast and dinner. After 1-week of administration, if no significant study drug related discomfort, the dose can increase to 100mg, Bid, PO. Otherwise, remain at the 50 mg level.
Probucol
250 mg Bid, PO after breakfast and dinner.
Cilostazol+Probucol
Control Group
Routine treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clarified diagnosis of type 2 diabetes mellitus
* Arteriosclerosis obliterans (ASO) is diagnosed (ASO diagnoses should meet at least one of the conditions as below:
* ABI\<1.0;
* The pulse of popliteal artery or dorsalis pedis artery is weeken significantly or is different between left and right sides
* Intermittent claudication, diagnosed as ASO by doctor
* Ultrasonogram showed that there was atherosclerotic plaque in lower limb within 1 year
* Informed Consent Form Signature
Exclusion Criteria
* Use one of the following drugs: other antiplatelet or anticoagulation agents except Aspirin, other hypolipidemic agents except Statins
* Type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetes mellitus
* Has severe ASO above Fontaine IIb,
* Hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tract hemorrhage, etc.)
* Had a myocardial infarction, angina pectoris, or cerebral infarction within the last 3 months
* Congestive heart failure
* Is pregnant, or potentially pregnant, or breastfeeding
* Severe hepatic insufficient or severe renal insufficiency (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 conditions that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
* Has severe complications (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)
* Other conditions that would exclude the subject from this study by doctor's judgement
40 Years
75 Years
ALL
No
Sponsors
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Otsuka Beijing Research Institute
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaohui Guo, M.D.
Role: PRINCIPAL_INVESTIGATOR
No 1 Hospital of Peking University
Locations
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Peking University First Hospital
Beijing, , China
Countries
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Other Identifiers
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246-08-802-01
Identifier Type: -
Identifier Source: org_study_id
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