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

This study has been completed.

First Received: September 12, 2005 Last Updated: February 12, 2009 History of Changes

Sponsor:	Rikshospitalet HF
Collaborator:	University of Oslo School of Pharmacy
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00199745

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 IV

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

Resource links provided by NLM:

MedlinePlus related topics: Muscle Disorders Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

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

Rikshospitalet HF

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

Study ID Numbers:	Muskelbiopsistudie Lipid05-06, S-05229 (REK - Sør), 13041 (NSD)
Study First Received:	September 12, 2005
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00199745 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services

Keywords provided by Rikshospitalet HF:

statin
statins
statin therapy
adverse events
side effect

Myotoxicity
atorvastatin
Statin Therapy
Atorvastatin Therapy

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Atorvastatin

ClinicalTrials.gov processed this record on February 08, 2010