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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120055

Enrollment

Unknown

Registered

2005-07-14

Start date

2005-02-28

Completion date

2005-04-30

Last updated

2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopathy

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

Interventions

DRUGAtorvastatin (Lipitor)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Statin toxicity	1 year	Rechallenge test of statin induce toxicity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026