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

NCT03884452 | Completed Phase 3

• 2 other identifiers: P01030MK-0653-018
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

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

  Baseline and Up to Week 12

• Percentage of participants with an Adverse Event (AE)

  Up to Week 12

Secondary Outcomes (9)

• Percent change from baseline in calculated LDL-C

  Baseline and Up to Week 12

• Percent change from baseline in Total Cholesterol (TC)

  Baseline and Up to Week 12

• Percent change from baseline in Triglycerides (TG)

  Baseline and Up to Week 12

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

  Baseline and Up to Week 12

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

  Baseline and Up to Week 12

Study Arms (6)

Atorvastatin 80 mg

EXPERIMENTAL

80 mg atorvastatin taken orally, once daily for 12 weeks

Drug: Atorvastatin; Drug: Placebo for Ezetimibe

Ezetimibe + Atorvastatin 40 mg

EXPERIMENTAL

10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks

Drug: Atorvastatin; Drug: Ezetimibe

Ezetimibe + Atorvastatin 80 mg

EXPERIMENTAL

10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks

Drug: Atorvastatin; Drug: Ezetimibe

Simvastatin 80 mg

EXPERIMENTAL

80 mg simvastatin taken orally, once daily for 12 weeks

Drug: Simvastatin; Drug: Placebo for Ezetimibe

Ezetimibe + Simvastatin 40 mg

EXPERIMENTAL

10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks

Drug: Simvastatin; Drug: Ezetimibe

Ezetimibe + Simvastatin 80 mg

EXPERIMENTAL

10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks

Drug: Simvastatin; Drug: Ezetimibe

Interventions

Atorvastatin DRUG

Tablets taken orally once daily in the morning

Atorvastatin 80 mg; Ezetimibe + Atorvastatin 40 mg; Ezetimibe + Atorvastatin 80 mg

Simvastatin DRUG

Tablets taken orally once daily in the morning or evening

Ezetimibe + Simvastatin 40 mg; Ezetimibe + Simvastatin 80 mg; Simvastatin 80 mg

Ezetimibe DRUG

Tablet taken orally once daily in the morning or evening

Ezetimibe + Atorvastatin 40 mg; Ezetimibe + Atorvastatin 80 mg; Ezetimibe + Simvastatin 40 mg; Ezetimibe + Simvastatin 80 mg

Placebo for Ezetimibe DRUG

Tablets taken orally once daily in the morning or evening

Atorvastatin 80 mg; Simvastatin 80 mg

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Gagne C, Gaudet D, Bruckert E; Ezetimibe Study Group. Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia. Circulation. 2002 May 28;105(21):2469-75. doi: 10.1161/01.cir.0000018744.58460.62.

  PMID: 12034651 RESULT

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Atorvastatin; Simvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; 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; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Azetidines; Azetines

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 21, 2019
• Study Start: May 3, 2000
• Primary Completion: May 24, 2001
• Study Completion: May 24, 2001
• Last Updated: May 10, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share