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NCT00199745 Clinical Trial

Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

Muscular Diseases Clinical Trial

Official title:
Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00199745
Other study ID # Muskelbiopsistudie Lipid05-06
Secondary ID S-05229 (REK - S
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated May 9, 2012
Start date October 2005
Est. completion date December 2008

Study information
Verified date May 2012
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• atorvastatin

Locations
Country Name City State
Norway Lipidklinikken, Rikshospitalet-Radiumhospitalet HF Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
Secondary Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group
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