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

NCT ID: NCT03884452

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-03

Study Completion Date

2001-05-24

Brief Summary

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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).

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Detailed Description

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Conditions

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Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atorvastatin 80 mg

80 mg atorvastatin taken orally, once daily for 12 weeks

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Tablets taken orally once daily in the morning

Placebo for Ezetimibe

Intervention Type DRUG

Tablets taken orally once daily in the morning or evening

Ezetimibe + Atorvastatin 40 mg

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Tablets taken orally once daily in the morning

Ezetimibe

Intervention Type DRUG

Tablet taken orally once daily in the morning or evening

Ezetimibe + Atorvastatin 80 mg

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Tablets taken orally once daily in the morning

Ezetimibe

Intervention Type DRUG

Tablet taken orally once daily in the morning or evening

Simvastatin 80 mg

80 mg simvastatin taken orally, once daily for 12 weeks

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Tablets taken orally once daily in the morning or evening

Placebo for Ezetimibe

Intervention Type DRUG

Tablets taken orally once daily in the morning or evening

Ezetimibe + Simvastatin 40 mg

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

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Tablets taken orally once daily in the morning or evening

Ezetimibe

Intervention Type DRUG

Tablet taken orally once daily in the morning or evening

Ezetimibe + Simvastatin 80 mg

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

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Tablets taken orally once daily in the morning or evening

Ezetimibe

Intervention Type DRUG

Tablet taken orally once daily in the morning or evening

Interventions

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Atorvastatin

Tablets taken orally once daily in the morning

Intervention Type DRUG

Simvastatin

Tablets taken orally once daily in the morning or evening

Intervention Type DRUG

Ezetimibe

Tablet taken orally once daily in the morning or evening

Intervention Type DRUG

Placebo for Ezetimibe

Tablets taken orally once daily in the morning or evening

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 12034651 (View on PubMed)

Other Identifiers

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P01030

Identifier Type: OTHER

Identifier Source: secondary_id

MK-0653-018

Identifier Type: OTHER

Identifier Source: secondary_id

P01030

Identifier Type: -

Identifier Source: org_study_id

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