Sitosterolemia Extension Study (0653-003)(COMPLETED)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00092807 |
Recruitment Status :
Completed
First Posted : September 28, 2004
Last Update Posted : February 16, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lipid Metabolism, Inborn Errors Heart Disease | Drug: MK0653, ezetimibe Drug: Comparator: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Primary Purpose: | Treatment |
Official Title: | 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 - 1 Year Open-Label Extension |
Actual Study Start Date : | February 12, 2001 |
Actual Primary Completion Date : | September 18, 2001 |
Actual Study Completion Date : | November 30, 2004 |

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

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092807
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |

Publications:
Responsible Party: | Organon and Co |
ClinicalTrials.gov Identifier: | NCT00092807 |
Other Study ID Numbers: |
P02257 2004_032 |
First Posted: | September 28, 2004 Key Record Dates |
Last Update Posted: | February 16, 2022 |
Last Verified: | February 2022 |
Homozygous Sitosterolemia |
Heart Diseases Metabolism, Inborn Errors Lipid Metabolism, Inborn Errors Cardiovascular Diseases Genetic Diseases, Inborn Metabolic Diseases Lipid Metabolism Disorders |
Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |