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

Last updated: March 24, 2025
Sponsor: Otsuka Beijing Research Institute
Overall Status: Completed

Phase

4

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Coronary Artery Disease

Treatment

Probucol

Cilostazol

Control Group

Clinical Study ID

NCT00823849
246-08-802-01
  • Ages 40-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 leastone of the conditions as below:

  • ABI<1.0;

  • The pulse of popliteal artery or dorsalis pedis artery is weeken significantlyor 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

Exclusion Criteria:

  • Has an allergic history to study drugs

  • Use one of the following drugs: other antiplatelet or anticoagulation agents exceptAspirin, other hypolipidemic agents except Statins

  • Type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetesmellitus

  • Has severe ASO above Fontaine IIb,

  • Hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tracthemorrhage, 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 timeshigher than the upper limit of the normal value range, or serum creatinine is 1.2times 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 ventricularcontractions)

  • 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, nonketotichyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologicdiseases, etc.)

  • Other conditions that would exclude the subject from this study by doctor'sjudgement

Study Design

Total Participants: 200
Treatment Group(s): 4
Primary Treatment: Probucol
Phase: 4
Study Start date:
October 01, 2008
Estimated Completion Date:
March 31, 2010

Study 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)

Connect with a study center

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

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