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

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: NCT00092898
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

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.

Condition or disease Intervention/treatment Phase
Lipid Metabolism, Inborn Errors Heart Disease Drug: MK0653, ezetimibe Drug: Comparator: placebo Phase 3

Detailed Description:
The duration of treatment is 26 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : October 2005





Primary Outcome Measures :
  1. Sitosterol concentrations after 26 weeks. [ Time Frame: After 26 weeks ]

Secondary Outcome Measures :
  1. Campesterol concentrations; Achilles tendon thickness; safety and tolerability.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT00092898


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
Study Data/Documents: CSR Snyopsis  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00092898    
Other Study ID Numbers: 0653-062
MK0653-062
2004_038
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Keywords provided by Organon and Co:
Sitosterolemia
Additional relevant MeSH terms:
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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