Differences in Atorvastatin Metabolite Ratios as a Diagno... | NCT00199745

Studies
Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

NCT00199745

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

May 10, 2012Estimated

Enrollment

53Estimated

Phase

Phase 4

Conditions

Muscular Diseases

Interventions

atorvastatin

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2012

Last Update Posted Date

May 10, 2012Estimated

Name	Class
University of Oslo School of Pharmacy	OTHER

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Estimated

Name	Type	Description	Arm Group Labels	Other Names
atorvastatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers

Secondary Outcomes

Measure	Description	Time Frame
Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected atorvastatin induced muscle adverse events
Signed informed consent
18 years of age or older
Able to donate blood samples
Ongoing treatment with atorvastatin (not necessary if patients only donate a muscle biopsy)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lipidklinikken, Rikshospitalet-Radiumhospitalet HF		Oslo	Oslo	0027	Norway

Condition Browse Module

MeSH Terms

ID	Term
D009135	Muscular Diseases
D000081030	Myotoxicity

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
S-05229 (REK - Sør)
13041 (NSD)