NCT00199745

Brief Summary

The primary objective of the study is to investigate whether differences in atorvastatin metabolite ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.

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 Oct 2005

Typical duration 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

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 10, 2012

Status Verified

May 1, 2012

Enrollment Period

3.2 years

First QC Date

September 12, 2005

Last Update Submit

May 9, 2012

Conditions

Muscular Diseases

Keywords

statinstatinsstatin therapyadverse eventsside effectMyotoxicityatorvastatinAtorvastatin Therapy

Outcome Measures

Primary Outcomes (1)

  • To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers

Secondary Outcomes (1)

  • Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group

Interventions

atorvastatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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
  • Ongoing treatment with atorvastatin (not necessary if patients only donate a muscle biopsy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

Oslo, Oslo County, 0027, Norway

Location

MeSH Terms

Conditions

Muscular DiseasesMyotoxicity

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Kjetil Retterstøl, MD

    Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

    PRINCIPAL INVESTIGATOR

  • Anders Åsberg, Associate Professor

    Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 10, 2012

Record last verified: 2012-05

Locations

NO(1)