Back to resultsDifferences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Primary Purpose
Muscular Diseases
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
About this trial
This is an interventional diagnostic trial for Muscular Diseases focused on measuring statin, statins, statin therapy, adverse events, side effect, Myotoxicity, atorvastatin, Atorvastatin Therapy
Eligibility Criteria
Inclusion Criteria: Suspected atorvastatin induced muscle adverse events Signed informed consent 18 years of age or older Able to donate blood samples Ongoing treatment with atorvastatin (not necessary if patients only donate a muscle biopsy)
Sites / Locations
- Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Outcomes
Primary Outcome Measures
To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
Secondary Outcome Measures
Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group
Full Information
NCT ID
NCT00199745
First Posted
September 12, 2005
Last Updated
May 9, 2012
Sponsor
Oslo University Hospital
Collaborators
University of Oslo School of Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT00199745
Brief Title
Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Official Title
Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo School of Pharmacy
4. Oversight
5. Study Description
Brief Summary
The primary objective of the study is to investigate whether differences in atorvastatin metabolite ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.
Detailed Description
The primary objective of the study is to investigate whether differences in atorvastatin metabolites ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Diseases
Keywords
statin, statins, statin therapy, adverse events, side effect, Myotoxicity, atorvastatin, Atorvastatin Therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Primary Outcome Measure Information:
Title
To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
Secondary Outcome Measure Information:
Title
Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Suspected atorvastatin induced muscle adverse events
Signed informed consent
18 years of age or older
Able to donate blood samples
Ongoing treatment with atorvastatin (not necessary if patients only donate a muscle biopsy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjetil Retterstøl, MD
Organizational Affiliation
Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anders Åsberg, Associate Professor
Organizational Affiliation
Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
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