Status:
COMPLETED
The Effect of Statin Medications on Muscle Performance (The STOMP Study)
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Muscular Diseases
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Statins are a group of medications that are used to lower cholesterol levels. Although serious side effects are rare, some people taking statins experience muscle pain or weakness. This study will eva...
Detailed Description
Statins are the most effective medications for reducing high cholesterol levels. They are extremely well tolerated by the majority of people but can produce a variety of muscle-related side effects in...
Eligibility Criteria
Inclusion
- Statin-naive (i.e., has never taken statins before)
Exclusion
- Previous use of statins
- Current treatment with cholesterol- or triglyceride-lowering drugs
- Impaired liver or kidney function
- Untreated hypothyroidism or hyperthyroidism
- Treatment with other medications known to increase risk of myopathy in atorvastatin-treated patients (e.g., cyclosporine, azithromycin, erythromycin, azole antifungals, fusidic acid)
- Existing infection requiring treatment with antibiotic therapy
- Consumption of greater that 1 quart of grapefruit juice per day
- Documented history of neuroleptic malignant syndrome
- Inherited muscle disorders or myopathy
- Known sickle cell trait
- Cancer within the 5 years prior to study entry
- Diabetes
- Currently being treated for high blood pressure
- Coronary artery disease
- Peripheral vascular disease
- Physical disability or previous injury that prevents safe exercise testing
- Pregnant or breastfeeding
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00609063
Start Date
January 1 2008
End Date
June 1 2011
Last Update
January 9 2012
Active Locations (3)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06102
2
University of Connecticut
Storrs, Connecticut, United States, 06269
3
University of Massachusetts
Amherst, Massachusetts, United States, 01003