Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Information source: Rikshospitalet-Radiumhospitalet HF
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Muscular Diseases
Intervention: atorvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Rikshospitalet-Radiumhospitalet HF Official(s) and/or principal investigator(s):
Kjetil Retterstøl, MD, Principal Investigator, Affiliation: Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Anders Åsberg, Associate Professor, Principal Investigator, Affiliation: Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo
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.
Clinical Details
Official title: Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Study design: Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
Secondary outcome: Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Lipidklinikken, Rikshospitalet-Radiumhospitalet HF, Oslo 0027, Norway; Recruiting
Martin P Bogsrud, medical student, Phone: +4795948194, Email: m.p.bogsrud@studmed.uio.no
Kjetil Retterstøl, MD, Phone: +4723075603, Email: kjetil.retterstol@rikshospitalet.no
Kjetil Retterstøl, MD, Principal Investigator
Martin P Bogsrud, medical student, Sub-Investigator
Gisle Langslet, MD, Sub-Investigator
Leiv Ose, MD, Sub-Investigator
Kjell E Berge, MD, Sub-Investigator
Additional Information
Starting date: October 2005
Last updated: April 18, 2007
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