Type 2 Diabetes MellitusPhase 4NCT00823849
Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker
A Phase 4 study testing Cilostazol, Probucol and Cilostazol+Probucol in people with Type 2 Diabetes Mellitus and Arteriosclerosis Obliterans, run by Otsuka Beijing Research Institute at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Arteriosclerosis Obliterans
- What is being tested?
- Cilostazol, Probucol and Cilostazol+Probucol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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
Read the 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)
- Being tested
- Cilostazol, Probucol, Cilostazol+Probucol, Control Group
- Keywords
- type 2 diabetes mellitus, with Arteriosclerosis obliterans
- Medical subject headings
- Diabetes Mellitus, Type 2, Arteriosclerosis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Also called pletaal
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.
ProbucolDrug
Also called Changtai
250 mg Bid, PO after breakfast and dinner.
Cilostazol+ProbucolDrug
Also called Pletaal and Changtai
Control GroupOther
Also called Routine treatment
Routine treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Cilostazol |
| 2 | Experimental | Not described Receives: Drug: Probucol |
| 3 | Experimental | Not described Receives: Drug: Cilostazol+Probucol |
| 4 | Other | Control Group, regular treatment Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaohui Guo, M.D., Principal investigator, No 1 Hospital of Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823849
- Sponsor's protocol ID
- 246-08-802-01
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2009
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00823849
- Acronym / sponsor ID
- 246-08-802-01
- Keywords
- type 2 diabetes mellitus, with Arteriosclerosis obliterans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cilostazol |
| 2 | Experimental | Drug: Probucol |
| 3 | Experimental | Drug: Cilostazol+Probucol |
| 4 | Other | Other: Control GroupControl Group, regular treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Informed Consent Form Signature
Key exclusion criteria (15 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CilostazolAlso: pletaalFrom 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. | Drug | 1 |
| ProbucolAlso: Changtai250 mg Bid, PO after breakfast and dinner. | Drug | 2 |
| Cilostazol+ProbucolAlso: Pletaal and Changtai | Drug | 3 |
| Control GroupAlso: Routine treatmentRoutine treatment | Other | 4 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohui Guo, M.D. principal investigator
No 1 Hospital of Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilostazol, Probucol and Cilostazol+Probucol in people with Type 2 Diabetes Mellitus and Arteriosclerosis Obliterans, run by Otsuka Beijing Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.