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

Primary Purpose

Familial Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Atorvastatin

Simvastatin

Ezetimibe

Placebo for Ezetimibe

About this trial

This is an interventional treatment trial for Familial Hypercholesterolemia

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Atorvastatin 80 mg

Ezetimibe + Atorvastatin 40 mg

Ezetimibe + Atorvastatin 80 mg

Simvastatin 80 mg

Ezetimibe + Simvastatin 40 mg

Ezetimibe + Simvastatin 80 mg

Arm Description

80 mg atorvastatin taken orally, once daily for 12 weeks

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

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

80 mg simvastatin taken orally, once daily for 12 weeks

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

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

Outcomes

Primary Outcome Measures

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

Percentage of participants with an Adverse Event (AE)

Secondary Outcome Measures

Percent change from baseline in calculated LDL-C

Percent change from baseline in Total Cholesterol (TC)

Percent change from baseline in Triglycerides (TG)

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

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

Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C)

Percent change from baseline in Apolipoprotein A-I (Apo A-I)

Percent change from baseline in Apolipoprotein B (Apo B)

Percent change from baseline in Lipoprotein(a) [Lp(a)]

Full Information

NCT ID

NCT03884452

First Posted

March 6, 2019

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT03884452

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 3, 2000 (Actual)

Primary Completion Date

May 24, 2001 (Actual)

Study Completion Date

May 24, 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Familial Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin 80 mg

Arm Type

Experimental

Arm Description

80 mg atorvastatin taken orally, once daily for 12 weeks

Arm Title

Ezetimibe + Atorvastatin 40 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Ezetimibe + Atorvastatin 80 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Simvastatin 80 mg

Arm Type

Experimental

Arm Description

80 mg simvastatin taken orally, once daily for 12 weeks

Arm Title

Ezetimibe + Simvastatin 40 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Ezetimibe + Simvastatin 80 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Tablets taken orally once daily in the morning

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

Tablets taken orally once daily in the morning or evening

Intervention Type

Drug

Intervention Name(s)

Ezetimibe

Intervention Description

Tablet taken orally once daily in the morning or evening

Intervention Type

Drug

Intervention Name(s)

Placebo for Ezetimibe

Intervention Description

Tablets taken orally once daily in the morning or evening

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline and Up to Week 12

Title

Percentage of participants with an Adverse Event (AE)

Time Frame

Up to Week 12

Secondary Outcome Measure Information:

Title

Percent change from baseline in calculated LDL-C

Time Frame

Baseline and Up to Week 12

Title

Percent change from baseline in Total Cholesterol (TC)

Time Frame

Baseline and Up to Week 12

Title

Percent change from baseline in Triglycerides (TG)

Time Frame

Baseline and Up to Week 12

Title

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

Time Frame

Baseline and Up to Week 12

Title

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

Time Frame

Baseline and Up to Week 12

Title

Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C)

Time Frame

Baseline and Up to Week 12

Title

Percent change from baseline in Apolipoprotein A-I (Apo A-I)

Time Frame

Baseline and Up to Week 12

Title

Percent change from baseline in Apolipoprotein B (Apo B)

Time Frame

Baseline and Up to Week 12

Title

Percent change from baseline in Lipoprotein(a) [Lp(a)]

Time Frame

Baseline and Up to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

12034651

Citation

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.

Results Reference

result

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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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