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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 February 2022 |
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Main ID: |
NCT00092898 |
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Date of registration:
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23/09/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
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Scientific title:
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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 |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00092898 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck Sharp & Dohme Corp. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lipid Metabolism, Inborn Errors
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Heart Disease
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Intervention(s)
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Drug: MK0653, ezetimibe
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Drug: Comparator: placebo
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Primary Outcome(s)
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Sitosterol concentrations after 26 weeks.
[Time Frame: After 26 weeks]
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Secondary Outcome(s)
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Campesterol concentrations; Achilles tendon thickness; safety and tolerability.
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Secondary ID(s)
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MK0653-062
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0653-062
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2004_038
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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