NCT00120055

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

First QC Date

July 7, 2005

Last Update Submit

December 2, 2014

Conditions

Myopathy

Outcome Measures

Primary Outcomes (1)

  • Statin toxicity

    Rechallenge test of statin induce toxicity

    1 year

Interventions

Atorvastatin (Lipitor)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • above 18 years
  • previous history of atorvastatin-associated myotoxicity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Anders Åsberg, PhD

    University of Oslo School of Pharmacy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 14, 2005

Study Start

February 1, 2005

Study Completion

April 1, 2005

Last Updated

December 3, 2014

Record last verified: 2014-12