Status:
COMPLETED
Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity
Lead Sponsor:
University of Oslo School of Pharmacy
Conditions:
Myopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 cont...
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...
Eligibility Criteria
Inclusion
- above 18 years
- previous history of atorvastatin-associated myotoxicity
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00120055
Start Date
February 1 2005
End Date
April 1 2005
Last Update
December 3 2014
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