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

NCT03884452 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-10

No results posted yet for this study

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).

Conditions

  • Familial Hypercholesterolemia

Interventions

DRUG

Atorvastatin

Tablets taken orally once daily in the morning

DRUG

Simvastatin

Tablets taken orally once daily in the morning or evening

DRUG

Ezetimibe

Tablet taken orally once daily in the morning or evening

DRUG

Placebo for Ezetimibe

Tablets taken orally once daily in the morning or evening

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-05-03
Primary Completion
2001-05-24
Completion
2001-05-24

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03884452 on ClinicalTrials.gov