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

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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.

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE May 3, 2000
Actual Primary Completion Date May 24, 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03884452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Familial Hypercholesterolemia
Intervention  ICMJE
  • Drug: Atorvastatin
    Tablets taken orally once daily in the morning
  • Drug: Simvastatin
    Tablets taken orally once daily in the morning or evening
  • Drug: Ezetimibe
    Tablet taken orally once daily in the morning or evening
  • Drug: Placebo for Ezetimibe
    Tablets taken orally once daily in the morning or evening
Study Arms  ICMJE
  • Experimental: Atorvastatin 80 mg
    80 mg atorvastatin taken orally, once daily for 12 weeks
    Interventions:
    • Drug: Atorvastatin
    • Drug: Placebo for Ezetimibe
  • Experimental: Ezetimibe + Atorvastatin 40 mg
    10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks
    Interventions:
    • Drug: Atorvastatin
    • Drug: Ezetimibe
  • Experimental: Ezetimibe + Atorvastatin 80 mg
    10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks
    Interventions:
    • Drug: Atorvastatin
    • Drug: Ezetimibe
  • Experimental: Simvastatin 80 mg
    80 mg simvastatin taken orally, once daily for 12 weeks
    Interventions:
    • Drug: Simvastatin
    • Drug: Placebo for Ezetimibe
  • Experimental: Ezetimibe + Simvastatin 40 mg
    10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks
    Interventions:
    • Drug: Simvastatin
    • Drug: Ezetimibe
  • Experimental: Ezetimibe + Simvastatin 80 mg
    10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks
    Interventions:
    • Drug: Simvastatin
    • Drug: Ezetimibe
Publications * Gagné 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2019)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 24, 2001
Actual Primary Completion Date May 24, 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03884452
Other Study ID Numbers  ICMJE P01030
P01030 ( Other Identifier: Schering-Plough Protocol Number )
MK-0653-018 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP