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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014