Peripheral Artery DiseasePhase 2NCT01142284
Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety
A Phase 2 study testing Cilostazol, Probucol in people with Peripheral Artery Disease, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Based upon evidence of efficacy and safety of both cilostazol and probucol administration in independent randomized controlled trials in PAD and CAD, the present trial seeks to investigate the effect of concomitant administration of cilostazol and probucol on FMD compared to each drug individually, as well as to… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Cilostazol, Probucol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 May 2010to 18 Dec 2012
- Phase
- Phase 2
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is ≥ 40 and <80 years at Screening.
- The subject has a diagnosis of PAD
- The subject has a diagnosis of CAD
- Stable background medical therapy over the past 3 months
- Taking 100mg/day of aspirin or 75mg/day of clopidogrel over the past 3 months
- Hyperlipidemia defined as a LDL cholesterol concentration > 70 mg/dL
- The subject is willing to participate in this study as documented by written informed consent
Who cannot join
- New diagnosis of PAD within 3 months.
- Currently taking cilostazol or has taken cilostazol
- Currently taking probucol or has taken probucol within the last 3 months
- Critical limb ischemia (CLI)
- Congestive heart failure
- Transient ischemic attack (TIA)
Show all 29Show fewer
- Endovascular peripheral or coronary revascularization procedure within 3 months
- Coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months
- Major surgical procedures within 3 months
- Uncontrolled hypertension
- Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus
- Diabetic complications of severe peripheral neuropathy or active retinopathy.
- Inflammatory bowel disease.
- Unstable angina
- QT prolongation
- Severe or life threatening ventricular arrhythmias
- History of syncope
- Serum creatinine > 2.5 mg/dL, Creatinine Clearance ≤25ml/min or renal failure requiring dialysis.
- History or evidence of any hematological or clotting disorder.
- Hematocrit ≤ 28% or ≥ 55%.
- AST or ALT > 3 times the upper limit of normal (ULN).
- Any form of chronic anticoagulation.
- Coagulopathies defined as an INR > 1.5
- History of malignant disease within 5 years.
- Acute or chronic hepatitis.
- Hemophilia or known increased risk of hemorrhage.
- Other clinically significant disorders resulting in a remaining life expectancy less than one year.
- Current alcohol or drug abuse.
- If female, the subject cannot be pregnant or breastfeeding and must be of non-childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety in Peripheral Artery Disease Subjects Complicated With Coronary Artery Disease.
Based upon evidence of efficacy and safety of both cilostazol and probucol administration in independent randomized controlled trials in PAD and CAD, the present trial seeks to investigate the effect of concomitant administration of cilostazol and probucol on FMD compared to each drug individually, as well as to evaluate biomarker measures and safety indices in this context.
Read the detailed description
Primary:
- To evaluate the effect of concomitant administration of cilostazol and probucol on the 12-week change in FMD from baseline compared, with individual drugs alone.
- To assess the safety of concomitant administration of cilostazol and probucol in peripheral artery disease (PAD) subjects complicated with coronary artery disease (CAD) as determined by physical examination, vital signs, adverse events (AEs), laboratory tests, ECGs.
Secondary:
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in FMD from baseline to Weeks 6 and 12.
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in metabolic, inflammatory, oxidative, and platelet biomarkers from baseline to Weeks 6 and 12.
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on the time course (over the 12-week treatment period) of changes in FMD and biomarkers levels.
- To assess the effect of drug withdrawal on these endpoints at follow-up (from Week 12 to Week 16).
- To explore the relationship between changes in FMD and changes in the biomarker levels at Week 12.
- Conditions
- Peripheral Artery Disease
- Being tested
- Cilostazol, Probucol
- Keywords
- Biomarker, Endothelial Function, Peripheral Artery Disease, Coronary Artery Disease, Flow Mediated Dilation, Cilostazol, Probucol
- Medical subject headings
- Peripheral Arterial Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol, ProbucolDrug
Treatment Group 1 (control) No cilostazol or probucol
Treatment Group 2 (cilostazol alone) 1 tablet cilostazol 100 mg PO BID
Treatment Group 3 (probucol alone) 1 tablet probucol 250 mg PO BID
Treatment Group 4 (concomitant cilostazol and probucol) 1 tablet cilostazol 100 mg PO BID, and 1 tablet probucol 250 mg PO BID
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Cilostazol, Probucol |
| Cilostazol | Experimental | cilostazol Receives: Drug: Cilostazol, Probucol |
| Probucol | Experimental | probucol Receives: Drug: Cilostazol, Probucol |
| Cilostazol + Probucol | Experimental | cilostazol and probucol Receives: Drug: Cilostazol, Probucol |
What is being measured
The primary outcome is the main question the study is designed to answer.
On the 12-week change in FMD / Safety
- To evaluate the effect of concomitant administration of cilostazol and probucol on the 12-week change
- To assess the safety of concomitant administration of cilostazol and probucol
Measured: 12 weeks
Secondary outcomes (1)
Changes in the biomarker and FMD
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in FMD
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control on biomarkers
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on the time course
- To assess the effect of drug withdrawal
- To explore the relationship between changes in FMD and changes in the biomarker levels
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 posted11 Jun 2010 (estimated)
- Study start19 May 2010
- Primary completion29 Nov 2012
- Study completion18 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142284
- Sponsor's protocol ID
- 021-KOA-0901i
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2010
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety in Peripheral Artery Disease Subjects Complicated With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT01142284
- Acronym / sponsor ID
- 021-KOA-0901i
- Conditions
- Peripheral Artery Disease
- Keywords
- Biomarker, Endothelial Function, Peripheral Artery Disease, Coronary Artery Disease, Flow Mediated Dilation, Cilostazol, Probucol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 May 2010 (actual)
- Primary completion
- 29 Nov 2012 (actual)
- Study completion
- 18 Dec 2012 (actual)
- First posted
- 11 Jun 2010 (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.
Based upon evidence of efficacy and safety of both cilostazol and probucol administration in independent randomized controlled trials in PAD and CAD, the present trial seeks to investigate the effect of concomitant administration of cilostazol and probucol on FMD compared to each drug individually, as well as to evaluate biomarker measures and safety indices in this context.
Detailed description
Primary:
- To evaluate the effect of concomitant administration of cilostazol and probucol on the 12-week change in FMD from baseline compared, with individual drugs alone.
- To assess the safety of concomitant administration of cilostazol and probucol in peripheral artery disease (PAD) subjects complicated with coronary artery disease (CAD) as determined by physical examination, vital signs, adverse events (AEs), laboratory tests, ECGs.
Secondary:
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in FMD from baseline to Weeks 6 and 12.
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in metabolic, inflammatory, oxidative, and platelet biomarkers from baseline to Weeks 6 and 12.
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on the time course (over the 12-week treatment period) of changes in FMD and biomarkers levels.
- To assess the effect of drug withdrawal on these endpoints at follow-up (from Week 12 to Week 16).
- To explore the relationship between changes in FMD and changes in the biomarker levels at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Cilostazol, ProbucolPlacebo |
| Cilostazol | Experimental | Drug: Cilostazol, Probucolcilostazol |
| Probucol | Experimental | Drug: Cilostazol, Probucolprobucol |
| Cilostazol + Probucol | Experimental | Drug: Cilostazol, Probucolcilostazol and probucol |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age is ≥ 40 and <80 years at Screening.
- The subject has a diagnosis of PAD
- The subject has a diagnosis of CAD
- Stable background medical therapy over the past 3 months
- Taking 100mg/day of aspirin or 75mg/day of clopidogrel over the past 3 months
Key exclusion criteria (29 listed)
- New diagnosis of PAD within 3 months.
- Currently taking cilostazol or has taken cilostazol
- Currently taking probucol or has taken probucol within the last 3 months
- Critical limb ischemia (CLI)
- Congestive heart failure
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, ProbucolTreatment Group 1 (control) No cilostazol or probucol Treatment Group 2 (cilostazol alone) 1 tablet cilostazol 100 mg PO BID Treatment Group 3 (probucol alone) 1 tablet probucol 250 mg PO BID Treatment Group 4 (concomitant cilostazol and probucol) 1 tablet cilostazol 100 mg PO BID, and 1 tablet probucol 250 mg PO BID | Drug | Cilostazol, Cilostazol + Probucol, Placebo, Probucol |
Primary outcome
On the 12-week change in FMD / Safety
Time frame: 12 weeks
1. To evaluate the effect of concomitant administration of cilostazol and probucol on the 12-week change 2. To assess the safety of concomitant administration of cilostazol and probucol
1 secondary outcome
Changes in the biomarker and FMD
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 18 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cilostazol, Probucol in people with Peripheral Artery Disease, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 7 inclusion and 29 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 18 Jul 2022. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the 12-week change in FMD / Safety (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 18 Jul 2022.