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NCT00120055 Clinical Trial

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

Myopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00120055
Other study ID # AVALIP04
Secondary ID
Status Completed
Phase Phase 4
First received July 7, 2005
Last updated December 2, 2014
Start date February 2005
Est. completion date April 2005

Study information
Verified date December 2014
Source University of Oslo School of Pharmacy
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin (Lipitor)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Oslo School of Pharmacy

Outcome
Type Measure Description Time frame Safety issue
Primary Statin toxicity Rechallenge test of statin induce toxicity 1 year Yes
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