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

This study has been completed.

First Received on July 7, 2005. Last Updated on July 13, 2005 History of Changes

Sponsor:	University of Oslo School of Pharmacy
Information provided by:	University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:	NCT00120055

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 IV

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

Drug Information available for: Atorvastatin Atorvastatin calcium

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 February 09, 2012