Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03884452 |
Recruitment Status :
Completed
First Posted : March 21, 2019
Last Update Posted : June 13, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Familial Hypercholesterolemia | Drug: Atorvastatin Drug: Simvastatin Drug: Ezetimibe Drug: Placebo for Ezetimibe | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | May 3, 2000 |
Actual Primary Completion Date : | May 24, 2001 |
Actual Study Completion Date : | May 24, 2001 |

Arm | Intervention/treatment |
---|---|
Experimental: Atorvastatin 80 mg
80 mg atorvastatin taken orally, once daily for 12 weeks
|
Drug: Atorvastatin
Tablets taken orally once daily in the morning Drug: Placebo for Ezetimibe Tablets taken orally once daily in the morning or evening |
Experimental: Ezetimibe + Atorvastatin 40 mg
10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks
|
Drug: Atorvastatin
Tablets taken orally once daily in the morning Drug: Ezetimibe Tablet taken orally once daily in the morning or evening |
Experimental: Ezetimibe + Atorvastatin 80 mg
10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks
|
Drug: Atorvastatin
Tablets taken orally once daily in the morning Drug: Ezetimibe Tablet taken orally once daily in the morning or evening |
Experimental: Simvastatin 80 mg
80 mg simvastatin taken orally, once daily for 12 weeks
|
Drug: Simvastatin
Tablets taken orally once daily in the morning or evening Drug: Placebo for Ezetimibe Tablets taken orally once daily in the morning or evening |
Experimental: Ezetimibe + Simvastatin 40 mg
10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks
|
Drug: Simvastatin
Tablets taken orally once daily in the morning or evening Drug: Ezetimibe Tablet taken orally once daily in the morning or evening |
Experimental: Ezetimibe + Simvastatin 80 mg
10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks
|
Drug: Simvastatin
Tablets taken orally once daily in the morning or evening Drug: Ezetimibe Tablet taken orally once daily in the morning or evening |
- Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly [ Time Frame: Baseline and Up to Week 12 ]
- Percentage of participants with an Adverse Event (AE) [ Time Frame: Up to Week 12 ]
- Percent change from baseline in calculated LDL-C [ Time Frame: Baseline and Up to Week 12 ]
- Percent change from baseline in Total Cholesterol (TC) [ Time Frame: Baseline and Up to Week 12 ]
- Percent change from baseline in Triglycerides (TG) [ Time Frame: Baseline and Up to Week 12 ]
- Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C) [ Time Frame: Baseline and Up to Week 12 ]
- Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C) [ Time Frame: Baseline and Up to Week 12 ]
- Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C) [ Time Frame: Baseline and Up to Week 12 ]
- Percent change from baseline in Apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline and Up to Week 12 ]
- Percent change from baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline and Up to Week 12 ]
- Percent change from baseline in Lipoprotein(a) [Lp(a)] [ Time Frame: Baseline and Up to Week 12 ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT03884452
Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT03884452 |
Other Study ID Numbers: |
P01030 P01030 ( Other Identifier: Schering-Plough Protocol Number ) MK-0653-018 ( Other Identifier: Merck Protocol Number ) |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | June 13, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
Hyperlipoproteinemia Type II Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |
Atorvastatin Simvastatin Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |