NCT00092807

Brief Summary

This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2001

Typical duration for phase_3

Status
completed

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

February 12, 2001

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2001

Completed
3 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
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2004

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

September 23, 2004

Last Update Submit

August 13, 2024

Conditions

Lipid Metabolism, Inborn ErrorsHeart Disease

Keywords

Homozygous Sitosterolemia

Outcome Measures

Primary Outcomes (1)

  • To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.

Secondary Outcomes (1)

  • Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK0653 10 mg/day in patients with homozygous sitosterolemia

Interventions

MK0653, ezetimibeDRUG
Comparator: placeboDRUG

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with elevated sitosterol levels while taking current medication

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

Related Publications (1)

  • Salen G, von Bergmann K, Lutjohann D, Kwiterovich P, Kane J, Patel SB, Musliner T, Stein P, Musser B; Multicenter Sitosterolemia Study Group. Ezetimibe effectively reduces plasma plant sterols in patients with sitosterolemia. Circulation. 2004 Mar 2;109(8):966-71. doi: 10.1161/01.CIR.0000116766.31036.03. Epub 2004 Feb 9.

    PMID: 14769702BACKGROUND

MeSH Terms

Conditions

Lipid Metabolism, Inborn ErrorsHeart Diseases

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2004

First Posted

September 28, 2004

Study Start

February 12, 2001

Primary Completion

September 18, 2001

Study Completion

November 30, 2004

Last Updated

August 15, 2024

Record last verified: 2022-02