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

Phase 4

Completed

• Conditions: Muscular Diseases

• Registration Number: NCT00199745
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Start: 2005-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers

Secondary Outcome Measures

Name	Time	Method
Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group

Trial Locations

Locations (1)

Lipidklinikken, Rikshospitalet-Radiumhospitalet HF; 🇳🇴 Oslo, Norway