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 range

40 Years – 75 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00823849

SponsorOtsuka Beijing Research Institute

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.