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

This study has been completed.
Sponsor:
Information provided by:
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00120055
First received: July 7, 2005
Last updated: December 2, 2014
Last verified: December 2014

July 7, 2005
December 2, 2014
February 2005
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Statin toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Rechallenge test of statin induce toxicity
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Complete list of historical versions of study NCT00120055 on ClinicalTrials.gov Archive Site
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Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity
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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.
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
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Myopathy
Drug: Atorvastatin (Lipitor)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2005
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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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00120055
AVALIP04
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University of Oslo School of Pharmacy
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Study Chair: Anders Åsberg, PhD University of Oslo School of Pharmacy
University of Oslo School of Pharmacy
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP