Text Size

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

This study has been completed.
Sponsor:
Collaborator:
University of Oslo School of Pharmacy
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00199745
First received: September 12, 2005
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Muscular Diseases
 Drug: atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

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

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

Estimated Enrollment: 53
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00199745     History of Changes
Other Study ID Numbers: Muskelbiopsistudie Lipid05-06, S-05229 (REK - Sør), 13041 (NSD)
Study First Received: September 12, 2005
Last Updated: May 9, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on May 16, 2013