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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199745

Enrollment

Registered

2005-09-20

Start date

2005-10-31

Completion date

2008-12-31

Last updated

2012-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Diseases

Keywords

statin, statins, statin therapy, adverse events, side effect, Myotoxicity, atorvastatin, Atorvastatin Therapy

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.

Interventions

DRUGatorvastatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers	—

Secondary

Measure	Time frame
Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group	—

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026