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

NCT02098460 | Completed Phase 4

• 1 other identifier: 260-13-806-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 thickness of mean carotid intima-media, anti-oxidation biomarkers and serum lipid profile.

Conditions

Severe Hypercholesterolemia

Keywords

the Achilles tendon; intima-media thickness

Outcome Measures

Primary Outcomes (1)

• the effect of concomitant administration of Probucol and Cilostazol on the mean achilles tendon thickness (ATT)

  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)

  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)

  2 years

• the effect of concomitant administration of Probucol and Cilostazol on biomarkers

  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)

  2 years

Study Arms (3)

Probucol,Cilostazol

PLACEBO COMPARATOR

Atorvastatin + Probucol-placebo + Cilostazol-placebo

Drug: Atorvastatin, Probucol, Cilostazol

Cilostazol

PLACEBO COMPARATOR

Atorvastatin + Probucol+ Cilostazol-placebo

Drug: Atorvastatin, Probucol, Cilostazol

Probucol, Cilostazol

ACTIVE COMPARATOR

Atorvastatin + Probucol + Cilostazol

Drug: Atorvastatin, Probucol, Cilostazol

Interventions

Atorvastatin, Probucol, Cilostazol DRUG

Cilostazol; Probucol, Cilostazol; Probucol,Cilostazol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject whose voluntary written informed consent is obtained for participation in this study;
• ≤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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Anzhen hospital

Beijing, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin; Probucol; Cilostazol

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Tetrazoles; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jie Lin, Dr

  Anzhen hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: October 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 27, 2025

Record last verified: 2014-03

Locations

CN (1)