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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lipid Metabolism, Inborn Errors Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Disease Heart Diseases Lipid Metabolism Disorders Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Sitosterolemia

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is 26 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK0653, ezetimibe

Drug

Comparator: placebo

Drug

Primary outcomes

Sitosterol concentrations after 26 weeks.

Time frame: After 26 weeks

Secondary outcomes

Campesterol concentrations; Achilles tendon thickness; safety and tolerability.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 28, 2004
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed