NCT00092833

Brief Summary

The purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2002

Typical duration for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

September 23, 2004

Last Update Submit

August 12, 2024

Conditions

Hypercholesterolemia, FamilialLipid Metabolism, Inborn Errors

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day

    3 years

Study Arms (1)

1

EXPERIMENTAL

Ezetimibe

Drug: Comparator: ezetimibe

Interventions

Comparator: ezetimibeDRUG

Ezetimibe (MK0653) 10 mg once daily for 3 years.

1

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Homozygous familial hypercholesterolemia or sitosterolemia

You may not qualify if:

  • Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipoproteinemia Type IILipid Metabolism, Inborn Errors

Condition Hierarchy (Ancestors)

Metabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2004

First Posted

September 28, 2004

Study Start

July 1, 2002

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02