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

Organon logo

Organon

Status and phase

Completed
Phase 3

Conditions

Lipid Metabolism, Inborn Errors
Heart Disease

Treatments

Drug: Comparator: placebo
Drug: MK0653, ezetimibe

Study type

Interventional

Funder types

Industry

Identifiers

NCT00092898
2004_038
0653-062
MK0653-062

Details and patient eligibility

About

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.

Full description

The duration of treatment is 26 weeks.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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