Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment Phase
Familial Hypercholesterolemia Drug: Atorvastatin Drug: Simvastatin Drug: Ezetimibe Drug: Placebo for Ezetimibe Phase 3

Layout table for study information
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03884452


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications of Results:
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03884452     History of Changes
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
Additional relevant MeSH terms:
Layout table for MeSH terms
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