Atherosclerosis Cerebral InfarctionPhase 4NCT00823875
Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject
A Phase 4 study testing Cilostazol group, Probucol group and Cilostazol + Probucol group in people with Atherosclerosis Cerebral Infarction, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
Randomized, control, open label, multicentre clinical study. The patient who are in accordance with subject inclusion and exclusion criteria will be randomized to A group: Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment + Probucol; D group: Routine treatment+ Cilostazol+ Probucol . Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Atherosclerosis Cerebral Infarction
- What is being tested?
- Cilostazol group, Probucol group and Cilostazol + Probucol group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40～80-year-old male or female
- By brain CT or MRI result, cerebral infarction is clarified diagnosis within 1 year
- With atherosclerosis, atherosclerosis should meet at least one of the conditions as below:
- Clarified diagnosis of type 2 diabetes before
- Clarified diagnosis of primary hypertension before
- Clarified diagnosis of Atherosclerotic stenosis in any 2 or more than 2 regions as cerebral artery, carotid, extremity artery and coronary by conformation of ultrasonic or angiography result
- Has Aspirin regularly for more than 1 month before registration
- Informed Consent Form signature
Who cannot join
- Has an allergic history to study drugs( including of Probucol and Cilostazol) and Aspirin
- Had lipid-lowing agents within the last 3 months ( except Statins)
- Had antiplatelet or anticoagulation agents within the last 3 months (except Aspirin)
- Had acute cerebral infarction within the last 1 month
- Has cardiogenic cerebral embolism
- At the registration ,Modified Rankin Scale ≥ 4
Show all 19Show fewer
- Hemorrhagic tendency or hemorrhagic disease (such as cerebral hemorrhage, gastrointestinal tract hemorrhage, etc.)
- Had a myocardial infarction, angina pectoris within the last 3 months
- Congestive heart failure
- Is pregnant, is potentially pregnant, or is breastfeeding
- Severe hepatic inadequacy or severe renal inadequacy (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 a condition that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
- Has severe diseases (such as, malignant tumor, severe anaemia, severe hematologic diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, etc.)
- Registered other clinical trails within the last 3 months
- Has vasculitis, moyamoya disease and other non-atherosclerosis vascular diseases
- Other conditions that could exclude the subject from this study by doctor's judgment
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---atherosclerosis Cerebral Infarction Patient as Study Subject
Randomized, control, open label, multicentre clinical study. The patient who are in accordance with subject inclusion and exclusion criteria will be randomized to A group: Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment + Probucol; D group: Routine treatment+ Cilostazol+ Probucol .
Read the detailed description
Efficacy index:
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Pharmacokinetics:
After 12 weeks of treatment, the study medication plasma concentration including of Probucol ,Cilostazol , Cilostazol metabolism OPC-13015 and OPC-13213 will be measured.
Safety evaluation:
Analysis the abnormality of Adverse Event, Vital Sign, Physical Examination, 12-lead ECG, and Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin) in 4 modality groups.
- Conditions
- Atherosclerosis Cerebral Infarction
- Being tested
- Cilostazol group, Probucol group, Cilostazol + Probucol group, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol groupDrug
Also called Pletaal
Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg（2 tablets）Bid.
Probucol groupDrug
Also called Changtai
Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
Cilostazol + Probucol groupDrug
Also called Pletaal and Changtai
Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg（2 tablets）Bid.
Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
control groupDrug
Also called Routine Treatment
routine treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Cilostazol group |
| 2 | Experimental | Not described Receives: Drug: Probucol group |
| 3 | Experimental | Not described Receives: Drug: Cilostazol + Probucol group |
| 4 | Other | Control Group Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Measured: 12 week
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 startMar 2009
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis Cerebral InfarctionStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yining Huang, M.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823875
- Sponsor's protocol ID
- 260-08-803-01
- Status last verified
- Jan 2010
- First submitted
- 15 Jan 2009
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. 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---atherosclerosis Cerebral Infarction Patient as Study Subject
- ClinicalTrials.gov ID
- NCT00823875
- Acronym / sponsor ID
- 260-08-803-01
- Conditions
- Atherosclerosis Cerebral Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 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.
Randomized, control, open label, multicentre clinical study. The patient who are in accordance with subject inclusion and exclusion criteria will be randomized to A group: Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment + Probucol; D group: Routine treatment+ Cilostazol+ Probucol .
Detailed description
Efficacy index:
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Pharmacokinetics:
After 12 weeks of treatment, the study medication plasma concentration including of Probucol ,Cilostazol , Cilostazol metabolism OPC-13015 and OPC-13213 will be measured.
Safety evaluation:
Analysis the abnormality of Adverse Event, Vital Sign, Physical Examination, 12-lead ECG, and Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin) in 4 modality groups.
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 group |
| 2 | Experimental | Drug: Probucol group |
| 3 | Experimental | Drug: Cilostazol + Probucol group |
| 4 | Other | Drug: control groupControl Group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 40～80-year-old male or female
- By brain CT or MRI result, cerebral infarction is clarified diagnosis within 1 year
- With atherosclerosis, atherosclerosis should meet at least one of the conditions as below:
- Has Aspirin regularly for more than 1 month before registration
- Informed Consent Form signature
Key exclusion criteria (19 listed)
- Has an allergic history to study drugs( including of Probucol and Cilostazol) and Aspirin
- Had lipid-lowing agents within the last 3 months ( except Statins)
- Had antiplatelet or anticoagulation agents within the last 3 months (except Aspirin)
- Had acute cerebral infarction within the last 1 month
- Has cardiogenic cerebral embolism
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 |
|---|---|---|
| Cilostazol groupAlso: PletaalCilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg（2 tablets）Bid. | Drug | 1 |
| Probucol groupAlso: ChangtaiProbucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner | Drug | 2 |
| Cilostazol + Probucol groupAlso: Pletaal and ChangtaiCilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg（2 tablets）Bid. Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner | Drug | 3 |
| control groupAlso: Routine Treatmentroutine treatment | Drug | 4 |
Primary outcome
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Time frame: 12 week
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 1 Dec 2010.
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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.
Yining Huang, M.D. principal investigator
Peking University First Hospital
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 group, Probucol group and Cilostazol + Probucol group in people with Atherosclerosis Cerebral Infarction, 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 19 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 1 Dec 2010. 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?
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups. (time frame: 12 week). 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 1 Dec 2010.