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

Primary Purpose

Type 2 Diabetes Mellitus, Arteriosclerosis Obliterans

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cilostazol
Probucol
Cilostazol+Probucol
Control Group
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes mellitus, with Arteriosclerosis obliterans

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1

2

3

4

Arm Description

Control Group

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2009
Last Updated
April 21, 2010
Sponsor
Otsuka Beijing Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00823849
Brief Title
Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker
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 Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Beijing Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
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: Adverse Event Vital Sign and Physical Examination 12-lead ECG Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Arteriosclerosis Obliterans
Keywords
type 2 diabetes mellitus, with Arteriosclerosis obliterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
No Intervention
Arm Description
Control Group
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
pletaal
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Probucol
Other Intervention Name(s)
Changtai
Intervention Description
250 mg Bid, PO after breakfast and dinner.
Intervention Type
Drug
Intervention Name(s)
Cilostazol+Probucol
Other Intervention Name(s)
Pletaal and Changtai
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Routine treatment
Intervention Description
Routine treatment
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohui Guo, M.D.
Organizational Affiliation
No 1 Hospital of Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

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

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