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

This study has been completed.
Information provided by:
Otsuka Beijing Research Institute Identifier:
First received: January 14, 2009
Last updated: April 21, 2010
Last verified: April 2010
  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 Intervention Phase
Type 2 Diabetes Mellitus
Arteriosclerosis Obliterans
Drug: Cilostazol
Drug: Probucol
Drug: Cilostazol+Probucol
Other: Control Group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by Otsuka Beijing Research Institute:

Primary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00823849

Peking University First Hospital
Beijing, China
Sponsors and Collaborators
Otsuka Beijing Research Institute
Principal Investigator: Xiaohui Guo, M.D. No 1 Hospital of Peking University
  More Information

Responsible Party: Quanjie Wei, Otsuka Beijing Research Institute Identifier: NCT00823849     History of Changes
Other Study ID Numbers: 246-08-802-01
Study First Received: January 14, 2009
Last Updated: April 21, 2010

Keywords provided by Otsuka Beijing Research Institute:
type 2 diabetes mellitus, with Arteriosclerosis obliterans

Additional relevant MeSH terms:
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 processed this record on May 25, 2017