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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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19 February 2015 |
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Main ID: |
NCT00890448 |
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Date of registration:
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27/04/2009 |
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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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Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate
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Scientific title:
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A Modified Case Control Study to Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00890448 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Canada
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Chile
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Czech Republic
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Finland
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Germany
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Latvia
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Netherlands
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Poland
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Russian Federation
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Slovakia
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South Africa
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United Kingdom
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Has experienced an alanine aminotransferase level greater than or equal to 5 times
the upper limit of normal, or concurrent elevation of alanine aminotransferase
greater than or equal to 3 times the upper limit of normal and bilirubin greater than
or equal to 2 times the upper limit of normal while participating in lapaquistat
acetate clinical studies.
Exclusion Criteria:
- None
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Toxicity
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Intervention(s)
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Other: Pharmacogenomic whole blood sampling
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Primary Outcome(s)
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Whole genome scanning using the Illumina 1M chip.
[Time Frame: Visit 2]
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Whole genome scanning using the Affymetrix 500K array chip.
[Time Frame: Visit 2]
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Candidate gene scanning using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) array.
[Time Frame: Visit 2]
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Secondary ID(s)
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U1111-1112-3768
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TAK-475_310
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2008-006906-41
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DOH-27-0410-2857
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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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