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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120055
First Posted: July 14, 2005
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oslo School of Pharmacy
  Purpose
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
Myopathy Drug: Atorvastatin (Lipitor) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00120055     History of Changes
Other Study ID Numbers: AVALIP04
First Submitted: July 7, 2005
First Posted: July 14, 2005
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