NCT00414531

Brief Summary

The primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse events, to elucidate whether differences in this ratio might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

May 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 3, 2014

Status Verified

August 1, 2009

Enrollment Period

4.1 years

First QC Date

December 20, 2006

Last Update Submit

December 2, 2014

Conditions

Myotoxicity of Atorvastatin Treatment

Outcome Measures

Primary Outcomes (1)

  • ratio of p-hydroxyatorvastatin to atorvastatin vs. myopathy

    march 2009

Secondary Outcomes (1)

  • ratio of atorvastatin lactone to atorvastatin vs. myopathy

    march 2009

Study Arms (1)

SIM

OTHER

Patients diagnosed to have or not to have Statin induced Myopathy

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

20 to 80 mg per day

SIM

Eligibility Criteria

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

You may qualify if:

  • Suspected atorvastatin induced muscle adverse events.
  • Signed informed consent.
  • years of age or older.
  • Able to donate blood samples.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet-Radiumhospitalet HF, Lipid clinic

Oslo, 0027, Norway

Location

Related Publications (1)

  • Skottheim IB, Bogsrud MP, Hermann M, Retterstol K, Asberg A. Atorvastatin metabolite measurements as a diagnostic tool for statin-induced myopathy. Mol Diagn Ther. 2011 Aug 1;15(4):221-7. doi: 10.1007/BF03256413.

    PMID: 21815705DERIVED

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Anders Åsberg, Ph.D.

    Universtiy of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

May 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 3, 2014

Record last verified: 2009-08

Locations

NO(1)