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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00199745 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
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Scientific title:
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Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00199745 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Norway
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Contacts
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Name:
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Anders Åsberg, Associate Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo |
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Name:
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Kjetil Retterstøl, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lipidklinikken, Rikshospitalet-Radiumhospitalet HF |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Muscular Diseases
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Intervention(s)
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Drug: atorvastatin
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Primary Outcome(s)
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To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
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Secondary Outcome(s)
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Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group
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Secondary ID(s)
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13041 (NSD)
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Muskelbiopsistudie Lipid05-06
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S-05229 (REK - Sør)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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