Clinical trial NCT00823849: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Arteriosclerosis Obliterans
Keywords: type 2 diabetes mellitus, with Arteriosclerosis obliterans
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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)

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

Primary outcomes:
measure: Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: No 1 Hospital of Peking University
name: Xiaohui Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: