Skip to main content
OpenTrials
Completed

NCT Number: NCT02098460

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anzhen hospital

Beijing, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Atorvastatin, Probucol, Cilostazol

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Otsuka Beijing Research Institute

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2014
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.