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...
Date First Received: September 12, 2005
Last Updated: February 12, 2009
Verified by: Rikshospitalet HF, February 2009
Clinical Trial Phase: Phase 4 | Start Date: October 2005
Overall Status: Completed
Estimated Enrollment: 53
Brief Summary
Official Title: “Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
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.
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Study Primary Completion Date: December 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: atorvastatin
Outcome Measures for this Clinical Trial
Primary Measures
- To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
Secondary Measures
- Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Rikshospitalet HF
Overall Clinical Trial Officials and Contacts
Kjetil Retterstøl, MD Principal Investigator Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Additional Information
Information obtained from ClinicalTrials.gov on September 02, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00199745
Study ID Number: Muskelbiopsistudie Lipid05-06
ClinicalTrials.gov Identifier: NCT00199745
Health Authority: Norway: The National Committees for Research Ethics in Norway
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
