Sitosterolemia Extension Study (0653-004)(COMPLETED)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092820

Enrollment

Registered

2004-09-28

Start date

2001-02-12

Completion date

2004-11-30

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

Homozygous Sitosterolemia

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.

Detailed description

The duration of treatment is 52 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

10 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with elevated sitosterol levels while taking current medication

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Plasma sitosterol levels after 52 weeks.	—

Secondary

Measure	Time frame
Plasma LDL-C and plasma campesterol. Safety and tolerability.	—

Outcome results

None listed

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