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

Tracking Information

First Received Date ^ICMJE

July 7, 2005

Last Updated Date

July 13, 2005

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00120055 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Myopathy

Intervention ^ICMJE

Drug: Atorvastatin (Lipitor)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

April 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00120055

Other Study ID Numbers ^ICMJE

AVALIP04

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Oslo School of Pharmacy

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Anders Åsberg, PhD

University of Oslo School of Pharmacy

Information Provided By

University of Oslo School of Pharmacy

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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