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

Familial Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884452
• Other study ID #: P01030
• Secondary ID: P01030MK-0653-01
• Status: Completed
• Phase: Phase 3
• Start date: May 3, 2000
• Est. completion date: May 24, 2001

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 24, 2001
• Est. primary completion date: May 24, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Atorvastatin
Tablets taken orally once daily in the morning
• Simvastatin
Tablets taken orally once daily in the morning or evening
• Ezetimibe
Tablet taken orally once daily in the morning or evening
• Placebo for Ezetimibe
Tablets taken orally once daily in the morning or evening

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly		Baseline and Up to Week 12
Primary	Percentage of participants with an Adverse Event (AE)		Up to Week 12
Secondary	Percent change from baseline in calculated LDL-C		Baseline and Up to Week 12
Secondary	Percent change from baseline in Total Cholesterol (TC)		Baseline and Up to Week 12
Secondary	Percent change from baseline in Triglycerides (TG)		Baseline and Up to Week 12
Secondary	Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C)		Baseline and Up to Week 12
Secondary	Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C)		Baseline and Up to Week 12
Secondary	Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C)		Baseline and Up to Week 12
Secondary	Percent change from baseline in Apolipoprotein A-I (Apo A-I)		Baseline and Up to Week 12
Secondary	Percent change from baseline in Apolipoprotein B (Apo B)		Baseline and Up to Week 12
Secondary	Percent change from baseline in Lipoprotein(a) [Lp(a)]		Baseline and Up to Week 12