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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-04-30

Brief Summary

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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

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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

Conditions

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Myopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Atorvastatin (Lipitor)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anders Åsberg, PhD

Role: STUDY_CHAIR

University of Oslo School of Pharmacy

Other Identifiers

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AVALIP04

Identifier Type: -

Identifier Source: org_study_id