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

Sponsor

Otsuka Beijing Research Institute (Industry)

Overall Status

Completed

CT.gov ID

NCT00823849

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

11.8

Patients Per Site Per Month

Study Details

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

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:

Adverse Event
Vital Sign and Physical Examination
12-lead ECG
Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)

Study Design

Study Type:

Interventional

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 :

Oct 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

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

Outcome Measures

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. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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