Severe HypercholesterolemiaPhase 4NCT02098460

To Compare the Effect of Concomitant Administration of Probucol and Cilostazol With Probucol Single Treatment on the Atherosclerosis Related Markers (Including the Thickness of the Achilles Tendon) and Evaluate Safety (Based on Atorvastatin Treatment) in Severe Hypercholesterolemia Subject

A Phase 4 study testing Atorvastatin, Probucol, Cilostazol in people with Severe Hypercholesterolemia, run by Otsuka Beijing Research Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the effect of concomitant administration of Probucol and Cilostazol (based on Atorvastatin treatment) on the atherosclerosis related markers (including the thickness of the Achilles tendon) in severe hypercholesterolemia subject, through the observation of the thickness of the Achilles tendon, the… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Severe Hypercholesterolemia
What is being tested?: Atorvastatin, Probucol, Cilostazol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 1 siteChina
Study dates: Oct 2013to Mar 2016
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject whose voluntary written informed consent is obtained for participation in this study;
18≤age≤70；
The subject with low-density lipoprotein cholesterol (LDL-C) ≥ 4.66 mmol/L (180 mg/dL) (the highest level either pre-treatment or on treatment);
The subject with ATT≥9mm.

Who cannot join

The subject with homozygous familial hyperlipidemia;
The subject who took Probucol within 6 months before the screening test;
The subject who took Cilostazol within 1 month before the screening test;
The subject who took Ezetimibe within 1 month before the screening test;
The subject who hoped to treat with Ezetimibe within this study period;
The subject being treated with Cyclosporine;

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The subject with a history of hypersensitivity to Probucol and Cilostazol;
The subject with a triglyceride (TG) level greater than 4.52 mmol/L (400 mg/dL);
The subject with diabetes: HbA1c level greater than 8.4% (NGSP);
The subject with New York Heart Association (NYHA) classification: Class III and IV;
The subject with a QTc interval greater than 450 msec (male) or 470 msec (female);
The subject with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole);
The subject with atrial fibrillation (including paroxysmal atrial fibrillation);
The subject with congestive cardiac failure or unstable angina;
The subject with liver and renal functions that satisfy the following criteria within 28 days prior to start of the investigational medicinal product (IMP) administration.
AST ≥100 IU/L, ALT≥100 IU/L
Serum creatinine ≥1.5 mg/dL (133 µmol/L)
The subject who are participating in another clinical trial;
Woman during pregnancy or potential pregnancy, and breastfeeding;
Women of childbearing potential who are not agree to use an appropriate method of contraception;
The subject who are not considered by the Investigators to be appropriate to participate in this study for any other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

Anzhen hospital
Beijing

Other trials in China

About this study

Read the detailed description

Multicenter, randomized, controlled, single-blinded, three parallel arms study. Group A: Atorvastatin + Probucol-placebo + Cilostazol-placebo Group B: Atorvastatin + Probucol + Cilostazol-placebo Group C: Atorvastatin + Probucol + Cilostazol

Conditions: Severe Hypercholesterolemia
Being tested: Atorvastatin, Probucol, Cilostazol
Keywords: the Achilles tendon, intima-media thickness
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atorvastatin, Probucol, CilostazolDrug

Study groups in NCT02098460
Study group	Role	What they receive
Probucol,Cilostazol	Placebo comparator	Atorvastatin + Probucol-placebo + Cilostazol-placebo Receives: Drug: Atorvastatin, Probucol, Cilostazol
Cilostazol	Placebo comparator	Atorvastatin + Probucol+ Cilostazol-placebo Receives: Drug: Atorvastatin, Probucol, Cilostazol
Probucol, Cilostazol	Active comparator	Atorvastatin + Probucol + Cilostazol Receives: Drug: Atorvastatin, Probucol, Cilostazol

What is being measured

The primary outcome is the main question the study is designed to answer.

the effect of concomitant administration of Probucol and Cilostazol on the mean achilles tendon thickness (ATT)
Measured: at Month 6, 12 and 24

Secondary outcomes (4)

the additional effect of concomitant administration of Probucol and Cilostazol on mean carotid intima-media thickness (IMT)
Measured: at Month 12 and 24
the preventive effect of concomitant administration of Probucol and Cilostazol on the incidence of cerebrovascular and cardiovascular events (including intervention)
Measured: 2 years
the effect of concomitant administration of Probucol and Cilostazol on biomarkers
Measured: 2 years
the safety of Probucol or concomitant administration of Probucol and Cilostazol as determined by physical examination, vital signs, adverse events (AEs), laboratory examinations and 12-lead electrocardiogram (ECGs)
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Mar 2016

First posted28 Mar 2014 (estimated)
Study startOct 2013
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe HypercholesterolemiaStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02098460
Sponsor's protocol ID: 260-13-806-01
Status last verified: Mar 2014
First submitted: 25 Mar 2014
Last updated: 27 Mar 2025
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
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Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingPhase 1
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
Cardiovascular, Metabolic Disease
Active, not recruitingPhase 3
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Atherosclerotic Cardiovascular Disease

All Severe Hypercholesterolemia trials

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: To Compare the Effect of Concomitant Administration of Probucol and Cilostazol With Probucol Single Treatment on the Atherosclerosis Related Markers (Including the Thickness of the Achilles Tendon) and Evaluate Safety (Based on Atorvastatin Treatment) in Severe Hypercholesterolemia Subject
ClinicalTrials.gov ID: NCT02098460
Acronym / sponsor ID: 260-13-806-01
Conditions: Severe Hypercholesterolemia
Keywords: the Achilles tendon, intima-media thickness
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 28 Mar 2014 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Probucol,Cilostazol	Placebo comparator	Drug: Atorvastatin, Probucol, CilostazolAtorvastatin + Probucol-placebo + Cilostazol-placebo
Cilostazol	Placebo comparator	Drug: Atorvastatin, Probucol, CilostazolAtorvastatin + Probucol+ Cilostazol-placebo
Probucol, Cilostazol	Active comparator	Drug: Atorvastatin, Probucol, CilostazolAtorvastatin + Probucol + Cilostazol

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

The subject whose voluntary written informed consent is obtained for participation in this study;
18≤age≤70；
The subject with low-density lipoprotein cholesterol (LDL-C) ≥ 4.66 mmol/L (180 mg/dL) (the highest level either pre-treatment or on treatment);
The subject with ATT≥9mm.

Key exclusion criteria (21 listed)

The subject with homozygous familial hyperlipidemia;
The subject who took Probucol within 6 months before the screening test;
The subject who took Cilostazol within 1 month before the screening test;
The subject who took Ezetimibe within 1 month before the screening test;
The subject who hoped to treat with Ezetimibe within this study period;

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
Atorvastatin, Probucol, Cilostazol	Drug	Cilostazol, Probucol, Cilostazol, Probucol,Cilostazol

Primary outcome

the effect of concomitant administration of Probucol and Cilostazol on the mean achilles tendon thickness (ATT)
Time frame: at Month 6, 12 and 24

4 secondary outcomes

the additional effect of concomitant administration of Probucol and Cilostazol on mean carotid intima-media thickness (IMT)
Time frame: at Month 12 and 24
the preventive effect of concomitant administration of Probucol and Cilostazol on the incidence of cerebrovascular and cardiovascular events (including intervention)
Time frame: 2 years
the effect of concomitant administration of Probucol and Cilostazol on biomarkers
Time frame: 2 years
the safety of Probucol or concomitant administration of Probucol and Cilostazol as determined by physical examination, vital signs, adverse events (AEs), laboratory examinations and 12-lead electrocardiogram (ECGs)
Time frame: 2 years

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.

Related trials for Severe Hypercholesterolemia

Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingPhase 1
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
Cardiovascular, Metabolic Disease
Active, not recruitingPhase 3
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Atherosclerotic Cardiovascular Disease

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.

Jie Lin, Dr principal investigator

Anzhen 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 Atorvastatin, Probucol, Cilostazol in people with Severe Hypercholesterolemia, 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 4 inclusion and 21 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. 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 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?

the effect of concomitant administration of Probucol and Cilostazol on the mean achilles tendon thickness (ATT) (time frame: at Month 6, 12 and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02098460.

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.