An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to An Ongoing Regimen of Ezetimibe 10 mg in Patients Homozygous Sitosterolemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092898

Enrollment

Registered

2004-09-28

Start date

2004-10-31

Completion date

2005-10-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease, Lipid Metabolism, Inborn Errors

Keywords

Sitosterolemia

Brief summary

This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.

Detailed description

The duration of treatment is 26 weeks.

Interventions

DRUGMK0653, ezetimibe

DRUGComparator: placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.

Exclusion criteria

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Design outcomes

Primary

Measure	Time frame
Sitosterol concentrations after 26 weeks.	After 26 weeks

Secondary

Measure	Time frame
Campesterol concentrations; Achilles tendon thickness; safety and tolerability.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026