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

University of Oslo (UIO) logo

University of Oslo (UIO)

Status and phase

Completed
Phase 4

Conditions

Muscular Diseases

Treatments

Drug: atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00199745
Muskelbiopsistudie Lipid05-06
13041 (NSD)
S-05229 (REK - Sør)

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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