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

February 7, 2022 updated by: Organon and Co

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Placebo for Ezetimibe
Tablets taken orally once daily in the morning or evening
Drug: Simvastatin
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: Ezetimibe
Tablet taken orally once daily in the morning or evening
Drug: Simvastatin
Tablets 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: Ezetimibe
Tablet taken orally once daily in the morning or evening
Drug: Simvastatin
Tablets taken orally once daily in the morning or evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly
Time Frame: Baseline and Up to Week 12
Baseline and Up to Week 12
Percentage of participants with an Adverse Event (AE)
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in calculated LDL-C
Time Frame: Baseline and Up to Week 12
Baseline and Up to Week 12
Percent change from baseline in Total Cholesterol (TC)
Time Frame: Baseline and Up to Week 12
Baseline and Up to Week 12
Percent change from baseline in Triglycerides (TG)
Time Frame: Baseline and Up to Week 12
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
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
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
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
Baseline and Up to Week 12
Percent change from baseline in Apolipoprotein B (Apo B)
Time Frame: Baseline and Up to Week 12
Baseline and Up to Week 12
Percent change from baseline in Lipoprotein(a) [Lp(a)]
Time Frame: Baseline and Up to Week 12
Baseline and Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2000

Primary Completion (Actual)

May 24, 2001

Study Completion (Actual)

May 24, 2001

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01030 (Other Identifier: Schering-Plough Protocol Number)
  • MK-0653-018 (Other Identifier: Merck Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Familial Hypercholesterolemia

Clinical Trials on Atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe