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

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ClinicalTrials.gov Identifier: NCT00199745
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 10, 2012
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Muscular Diseases Drug: atorvastatin Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Study Start Date : October 2005
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Disorders
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers

Secondary Outcome Measures :
  1. Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199745


Locations
Norway
Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of Oslo School of Pharmacy
Investigators
Principal Investigator: Kjetil Retterstøl, MD Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Principal Investigator: Anders Åsberg, Associate Professor Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo
More Information

ClinicalTrials.gov Identifier: NCT00199745     History of Changes
Other Study ID Numbers: Muskelbiopsistudie Lipid05-06
S-05229 (REK - Sør)
13041 (NSD)
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012

Keywords provided by Oslo University Hospital:
statin
statins
statin therapy
adverse events
side effect
Myotoxicity
atorvastatin
Atorvastatin Therapy

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors