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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigations on Differences in Atorvastatin Metabolites Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

NCT00414531

Myotoxicity of Atorvastatin Treatment

COMPLETED PHASE4

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

NCT00120055

Myopathy

COMPLETED PHASE4

STATIN: Web-based Investigation of Side Effects

NCT02781064

Cardiovascular Disease

COMPLETED PHASE4

Phase I Drug-drug Interaction of Omega-3 and Atorvastatin

NCT03438955

Hyperlipidemia, Hypertriglyceridemia

UNKNOWN PHASE1

MUscle Side-Effects of Atorvastatin in Coronary Patients

NCT03874156

Statin Adverse Reaction

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

atorvastatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes