Back to resultsAssociation 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
About this trial
This is an interventional diagnostic trial for Myopathy
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
Sites / Locations
Outcomes
Primary Outcome Measures
Statin toxicity
Rechallenge test of statin induce toxicity
Secondary Outcome Measures
Full Information
NCT ID
NCT00120055
First Posted
July 7, 2005
Last Updated
December 2, 2014
Sponsor
University of Oslo School of Pharmacy
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
We'll reach out to this number within 24 hrs