Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-Induced Myotoxicity
Information source: University of Oslo School of Pharmacy
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myopathy
Intervention: Atorvastatin (Lipitor) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Oslo School of Pharmacy Official(s) and/or principal investigator(s):
Anders Åsberg, PhD, Study Chair, Affiliation: University of Oslo School of Pharmacy
Summary
The aim of this study is to investigate whether the pharmacokinetics of atorvastatin and/or
its metabolites is altered in patients with confirmed atorvastatin-induced myopathy compared
to healthy controls.
Clinical Details
Study design: Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Detailed description:
A 24 hour pharmacokinetic investigation of atorvastatin and metabolites will be performed in
15 patients with a history of atorvastatin - induced myotoxicity. The possible link to
relevant mutations in SLCO1B1, CYP3A5 and MDR1 will be also be investigated
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
above 18 years
previous history of atorvastatin-associated myotoxicity
Exclusion Criteria:
current treatment with drugs or herbal remedies with known pharmacokinetic interaction
potential with atorvastatin
previous CK levels above ten times the upper limit of normal range
pregnancy and persistent muscular complaints after a four week wash-out period of statin
treatment
Locations and Contacts
Additional Information
Starting date: February 2005
Ending date: April 2005
Last updated: July 13, 2005
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