Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120055
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2005-07-07
Brief Title:
Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity
Sponsor:
University of Oslo School of Pharmacy
Organization:
University of Oslo School of Pharmacy
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate whether the pharmacokinetics of atorvastatin andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None