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

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ClinicalTrials.gov Identifier: NCT00120055
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : December 3, 2014
Sponsor:
Information provided by:
University of Oslo School of Pharmacy

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 controls.

Condition or disease Intervention/treatment Phase
Myopathy Drug: Atorvastatin (Lipitor) Phase 4

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 Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : February 2005
Study Completion Date : April 2005

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Primary Outcome Measures :
  1. Statin toxicity [ Time Frame: 1 year ]
    Rechallenge test of statin induce toxicity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120055


Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Study Chair: Anders Åsberg, PhD University of Oslo School of Pharmacy

ClinicalTrials.gov Identifier: NCT00120055     History of Changes
Other Study ID Numbers: AVALIP04
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors