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Completed

NCT Number: NCT03884452

Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)

The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).

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Key information

Conditions

Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • With a diagnosis of homozygous familial hypercholesterolemia
  • All females must have a negative pregnancy test prior to study entry. Women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study, until one month after treatment.
  • Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during the study period. ERT, HRT or raloxifene cannot be changed during study period.
  • Must follow prescribed or stricter diet, and demonstrate completion of Diet Diaries

Exclusion criteria

  • A history of mental instability, drug or alcohol abuse; or have been treated or are being treated for severe psychiatric illness which, in the opinion of the Investigator, may interfere with optimal participation in the study.
  • With underlying disease likely to limit life span to less than 1 year.
  • Have previously been randomized in any studies examining ezetimibe
  • Pregnant or lactating women.
  • With known hypersensitivity or any contraindication to statin therapy.

Treatment and study plan

atorvastatin

Drug

Tablets taken orally once daily in the morning

simvastatin

Drug

Tablets taken orally once daily in the morning or evening

ezetimibe

Drug

Tablet taken orally once daily in the morning or evening

Placebo for Ezetimibe

Drug

Tablets taken orally once daily in the morning or evening

Primary outcomes

  1. Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly

    Time frame: Baseline and Up to Week 12

  2. Percentage of participants with an Adverse Event (AE)

    Time frame: Up to Week 12

Secondary outcomes

  1. Percent change from baseline in calculated LDL-C

    Time frame: Baseline and Up to Week 12

  2. Percent change from baseline in Total Cholesterol (TC)

    Time frame: Baseline and Up to Week 12

  3. Percent change from baseline in Triglycerides (TG)

    Time frame: Baseline and Up to Week 12

  4. Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C)

    Time frame: Baseline and Up to Week 12

  5. Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C)

    Time frame: Baseline and Up to Week 12

  6. Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C)

    Time frame: Baseline and Up to Week 12

  7. Percent change from baseline in Apolipoprotein A-I (Apo A-I)

    Time frame: Baseline and Up to Week 12

  8. Percent change from baseline in Apolipoprotein B (Apo B)

    Time frame: Baseline and Up to Week 12

  9. Percent change from baseline in Lipoprotein(a) [Lp(a)]

    Time frame: Baseline and Up to Week 12

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Mar 21, 2019
Registry last updated
May 10, 2024

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.

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