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Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-Induced Myotoxicity

This study has been completed.
Sponsor:
Information provided by:
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00120055
First received: July 7, 2005
Last updated: July 13, 2005
Last verified: June 2005
History of Changes
  Purpose

The aim of this study is to investigate whether the pharmacokinetics of atorvastatin and/or its metabolites is altered in patients with confirmed atorvastatin-induced myopathy compared to healthy controls.


Condition Intervention Phase
Myopathy
 Drug: Atorvastatin (Lipitor)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

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

Further study details as provided by University of Oslo School of Pharmacy:

Study Start Date: February 2005
Estimated Study Completion Date: April 2005
Detailed Description:

A 24 hour pharmacokinetic investigation of atorvastatin and metabolites will be performed in 15 patients with a history of atorvastatin -induced myotoxicity. The possible link to relevant mutations in SLCO1B1, CYP3A5 and MDR1 will be also be investigated

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • above 18 years
  • previous history of atorvastatin-associated myotoxicity

Exclusion Criteria:

  • current treatment with drugs or herbal remedies with known pharmacokinetic interaction potential with atorvastatin
  • previous CK levels above ten times the upper limit of normal range
  • pregnancy and persistent muscular complaints after a four week wash-out period of statin treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120055

Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Study Chair: Anders Åsberg, PhD University of Oslo School of Pharmacy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00120055     History of Changes
Other Study ID Numbers: AVALIP04
Study First Received: July 7, 2005
Last Updated: July 13, 2005
Health Authority: Norway: Norwegian Medicines Agency

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 October 16, 2012