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

March 24, 2025 updated by: Otsuka Beijing Research Institute

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

  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

Study Overview

Status

Completed

Conditions

Intervention / 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)

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • pletaal
Experimental: 2
Drug: Probucol
250 mg Bid, PO after breakfast and dinner.
Other Names:
  • Changtai
Experimental: 3
Drug: Cilostazol+Probucol
Other Names:
  • Pletaal and Changtai
Other: 4
Control Group, regular treatment
Other: Control Group
Routine treatment
Other Names:
  • Routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Beijing Research Institute

Investigators

  • Principal Investigator: Xiaohui Guo, M.D., No 1 Hospital of Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimated)

January 16, 2009

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 246-08-802-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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