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

Organon

Status and phase: Completed; Phase 3

Conditions: Familial Hypercholesterolemia

Treatments: Drug: Atorvastatin; Drug: Ezetimibe; Drug: Simvastatin; Drug: Placebo for Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT03884452

P01030 (Other Identifier)

MK-0653-018 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 6 patient groups

Atorvastatin 80 mg

Experimental group

Description:

80 mg atorvastatin taken orally, once daily for 12 weeks

Treatment:

Drug: Placebo for Ezetimibe

Drug: Atorvastatin

Ezetimibe + Atorvastatin 40 mg

Experimental group

Description:

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

Treatment:

Drug: Ezetimibe

Drug: Atorvastatin

Ezetimibe + Atorvastatin 80 mg

Experimental group

Description:

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

Treatment:

Drug: Ezetimibe

Drug: Atorvastatin

Simvastatin 80 mg

Experimental group

Description:

80 mg simvastatin taken orally, once daily for 12 weeks

Treatment:

Drug: Placebo for Ezetimibe

Drug: Simvastatin

Ezetimibe + Simvastatin 40 mg

Experimental group

Description:

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

Treatment:

Drug: Ezetimibe

Drug: Simvastatin

Ezetimibe + Simvastatin 80 mg

Experimental group

Description:

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

Treatment:

Drug: Ezetimibe

Drug: Simvastatin