Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate
A Modified Case Control Study to Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate
4 other identifiers
observational
66
14 countries
19
Brief Summary
The purpose of this study is to examine the genetic contribution to the mechanism of lapaquistat acetate- induced hepatic abnormalities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2009
Shorter than P25 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 24, 2012
May 1, 2012
1 year
April 27, 2009
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Whole genome scanning using the Illumina 1M chip.
Visit 2
Whole genome scanning using the Affymetrix 500K array chip.
Visit 2
Candidate gene scanning using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) array.
Visit 2
Study Arms (1)
Lapaquistat acetate participants
Interventions
10 mL, whole blood, one sample on Visit 2
Eligibility Criteria
Subjects who participated in lapaquistat acetate phase 2 and phase 3 clinical studies
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (19)
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Córdoba, Argentina
Unknown Facility
Québec, Canada
Unknown Facility
Sainte-Foy, Canada
Unknown Facility
Santiago, Chile
Unknown Facility
Havírov-Šumbark, Czechia
Unknown Facility
Oulu, Finland
Unknown Facility
Nuremberg, Germany
Unknown Facility
Riga, Latvia
Unknown Facility
Groningen, Netherlands
Unknown Facility
Gdansk, Poland
Unknown Facility
Moscow, Russia
Unknown Facility
Saratov, Russia
Unknown Facility
Žilina, Slovakia
Unknown Facility
Johannesburg, South Africa
Unknown Facility
Glasgow, Scotland, United Kingdom
Biospecimen
Pharmacogenomic whole blood sample
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 29, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
May 24, 2012
Record last verified: 2012-05