Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oslo School of Pharmacy
• Treatments: Atorvastatin; Atorvastatin Calcium

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