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Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823849
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : April 22, 2010
Information provided by:
Otsuka Beijing Research Institute

Brief Summary:
  1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
  2. To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Arteriosclerosis Obliterans Drug: Cilostazol Drug: Probucol Drug: Cilostazol+Probucol Other: Control Group Phase 4

Detailed Description:

Efficacy evaluation:

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Cilostazol

Arm Intervention/treatment
Experimental: 1 Drug: 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.
Other Name: pletaal

Experimental: 2 Drug: Probucol
250 mg Bid, PO after breakfast and dinner.
Other Name: Changtai

Experimental: 3 Drug: Cilostazol+Probucol
Other Name: Pletaal and Changtai

No Intervention: 4
Control Group
Other: Control Group
Routine treatment
Other Name: Routine treatment

Primary Outcome Measures :
  1. Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 40~75-year-old male or female
  • 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:

  • Has an allergic history to study drugs
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823849

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Peking University First Hospital
Beijing, China
Sponsors and Collaborators
Otsuka Beijing Research Institute
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Principal Investigator: Xiaohui Guo, M.D. No 1 Hospital of Peking University
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Responsible Party: Quanjie Wei, Otsuka Beijing Research Institute Identifier: NCT00823849    
Other Study ID Numbers: 246-08-802-01
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: April 22, 2010
Last Verified: April 2010
Keywords provided by Otsuka Beijing Research Institute:
type 2 diabetes mellitus, with Arteriosclerosis obliterans
Additional relevant MeSH terms:
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Arteriosclerosis Obliterans
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents