Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker (NCT00823849) | Clinical Trial Compass
CompletedPhase 4
Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker
China200 participantsStarted 2008-10
Plain-language 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
Who can participate
Age range40 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 arr…
What they're measuring
1
Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment.