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

This study has been completed.
Information provided by:
University of Oslo School of Pharmacy Identifier:
First received: July 7, 2005
Last updated: December 2, 2014
Last verified: December 2014
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 Intervention Phase
Drug: Atorvastatin (Lipitor)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • Statin toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Rechallenge test of statin induce toxicity

Study Start Date: February 2005
Estimated Study Completion Date: April 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00120055

Sponsors and Collaborators
University of Oslo School of Pharmacy
Study Chair: Anders Åsberg, PhD University of Oslo School of Pharmacy
  More Information Identifier: NCT00120055     History of Changes
Other Study ID Numbers: AVALIP04 
Study First Received: July 7, 2005
Last Updated: December 2, 2014
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 30, 2016