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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

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ClinicalTrials.gov Identifier: NCT02098460
Recruitment Status : Unknown
Verified March 2014 by Otsuka Beijing Research Institute.
Recruitment status was:  Recruiting
First Posted : March 28, 2014
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Beijing Research Institute

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.

Condition or disease Intervention/treatment Phase
Severe Hypercholesterolemia Drug: Atorvastatin, Probucol, Cilostazol Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2013
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Probucol,Cilostazol
Atorvastatin + Probucol-placebo + Cilostazol-placebo
Placebo Comparator: Cilostazol
Atorvastatin + Probucol+ Cilostazol-placebo
Drug: Atorvastatin, Probucol, Cilostazol
Active Comparator: Probucol, Cilostazol
Atorvastatin + Probucol + Cilostazol
Drug: Atorvastatin, Probucol, Cilostazol



Primary Outcome Measures :
  1. the effect of concomitant administration of Probucol and Cilostazol on the mean achilles tendon thickness (ATT) [ Time Frame: at Month 6, 12 and 24 ]

Secondary Outcome Measures :
  1. the additional effect of concomitant administration of Probucol and Cilostazol on mean carotid intima-media thickness (IMT) [ Time Frame: at Month 12 and 24 ]
  2. the preventive effect of concomitant administration of Probucol and Cilostazol on the incidence of cerebrovascular and cardiovascular events (including intervention) [ Time Frame: 2 years ]
  3. the effect of concomitant administration of Probucol and Cilostazol on biomarkers [ Time Frame: 2 years ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject whose voluntary written informed consent is obtained for participation in this study;
  2. 18≤age≤70;
  3. 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);
  4. The subject with ATT≥9mm.

Exclusion Criteria:

  1. The subject with homozygous familial hyperlipidemia;
  2. The subject who took Probucol within 6 months before the screening test;
  3. The subject who took Cilostazol within 1 month before the screening test;
  4. The subject who took Ezetimibe within 1 month before the screening test;
  5. The subject who hoped to treat with Ezetimibe within this study period;
  6. The subject being treated with Cyclosporine;
  7. The subject with a history of hypersensitivity to Probucol and Cilostazol;
  8. The subject with a triglyceride (TG) level greater than 4.52 mmol/L (400 mg/dL);
  9. The subject with diabetes: HbA1c level greater than 8.4% (NGSP);
  10. The subject with New York Heart Association (NYHA) classification: Class III and IV;
  11. The subject with a QTc interval greater than 450 msec (male) or 470 msec (female);
  12. The subject with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole);
  13. The subject with atrial fibrillation (including paroxysmal atrial fibrillation);
  14. The subject with congestive cardiac failure or unstable angina;
  15. 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)
  16. The subject who are participating in another clinical trial;
  17. Woman during pregnancy or potential pregnancy, and breastfeeding;
  18. Women of childbearing potential who are not agree to use an appropriate method of contraception;
  19. The subject who are not considered by the Investigators to be appropriate to participate in this study for any other reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098460


Locations
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China
Anzhen hospital Recruiting
Beijing, China
Contact: Jie Lin, Dr    00861064412431      
Principal Investigator: Jie Lin, Dr         
Sponsors and Collaborators
Otsuka Beijing Research Institute
Investigators
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Principal Investigator: Jie Lin, Dr Anzhen hospital
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Responsible Party: Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT02098460    
Other Study ID Numbers: 260-13-806-01
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014
Keywords provided by Otsuka Beijing Research Institute:
the Achilles tendon
intima-media thickness
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cilostazol
Atorvastatin
Probucol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Antioxidants