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

Primary Purpose

Myopathy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atorvastatin (Lipitor)
Sponsored by
University of Oslo School of Pharmacy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Statin toxicity
    Rechallenge test of statin induce toxicity

    Secondary Outcome Measures

    Full Information

    First Posted
    July 7, 2005
    Last Updated
    December 2, 2014
    Sponsor
    University of Oslo School of Pharmacy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00120055
    Brief Title
    Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Oslo School of Pharmacy

    4. Oversight

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopathy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin (Lipitor)
    Primary Outcome Measure Information:
    Title
    Statin toxicity
    Description
    Rechallenge test of statin induce toxicity
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anders Åsberg, PhD
    Organizational Affiliation
    University of Oslo School of Pharmacy
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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