Clinical Trials Directory

Trials / Completed

CompletedNCT00120055

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
Sponsor
University of Oslo School of Pharmacy · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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

Conditions

Interventions

TypeNameDescription
DRUGAtorvastatin (Lipitor)

Timeline

Start date
2005-02-01
Completion
2005-04-01
First posted
2005-07-14
Last updated
2014-12-03

Source: ClinicalTrials.gov record NCT00120055. Inclusion in this directory is not an endorsement.