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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: |
NCT00092807 |
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Date of registration:
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23/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sitosterolemia Extension Study (0653-003)(COMPLETED)
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Scientific title:
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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 |
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Date of first enrolment:
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February 12, 2001 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00092807 |
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Study type:
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Interventional |
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Study design:
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Primary purpose: Treatment.
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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:
- 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.
Age minimum:
10 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Disease
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Lipid Metabolism, Inborn Errors
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Intervention(s)
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Drug: Comparator: placebo
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Drug: MK0653, ezetimibe
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Primary Outcome(s)
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To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
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Secondary Outcome(s)
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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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Secondary ID(s)
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P02257
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2004_032
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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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