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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03884452
Other study ID # P01030
Secondary ID P01030MK-0653-01
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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)

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 — 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
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