Status:
COMPLETED
Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate
Lead Sponsor:
Takeda
Conditions:
Toxicity
Eligibility:
All Genders
Brief Summary
The purpose of this study is to examine the genetic contribution to the mechanism of lapaquistat acetate- induced hepatic abnormalities.
Detailed Description
This is a modified case control study to investigate the association of genotype with phenotype in subjects who experienced alanine aminotransferase and bilirubin derangements following exposure to la...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00890448
Start Date
May 1 2009
End Date
May 1 2010
Last Update
May 24 2012
Active Locations (19)
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1
Jacksonville, Florida, United States
2
Jupiter, Florida, United States
3
Idaho Falls, Idaho, United States
4
Richmond, Virginia, United States