Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00609063
Other study ID # 552
Secondary ID R01HL081893-01A2
Status Completed
Phase N/A
First received January 25, 2008
Last updated January 5, 2012
Start date January 2008
Est. completion date June 2011

Study information

Verified date January 2012
Source Hartford Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 evaluate the number of people who experience mild muscle complaints and will determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise performance.


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 some people. Of these side effects, the most serious is rhabdomyolysis, which involves muscle fiber damage that can begin as muscle pain and progress to a loss of muscle cells, kidney failure, and death. While rhabdomyolysis is extremely rare, some people experience the more common muscle-related side effects of statins, such as muscle pain (known as "myalgia"), cramps, and weakness. These more common side effects warrant attention because they may limit the use of statins, affect mobility, and increase the risk of injury in older individuals. Also, the term "muscle weakness," often used by patients and their doctors, is not well defined and can refer to a wide range of complaints from simple fatigue to an actual inability to perform activities of daily living. It is important to describe and quantify in more detail the muscle-related side effects associated with statins. The purpose of this study is to determine the incidence of statin-induced mild muscle complaints and to determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise performance.

This study will enroll healthy people who have never received statin medications. First, participants will attend three study visits over a period of 2 weeks. These study visits will include blood collection, questionnaires on physical activity and pain, vital sign measurements, and body measurements, including height, weight, and head circumference. Participants will also complete two cardiopulmonary exercise stress tests on a treadmill and will undergo arm and leg strength testing. Some participants may undergo a muscle biopsy. Participants will then be randomly assigned to receive either 80 mg of atorvastatin or placebo on a daily basis for 6 months. Blood will be collected again at Month 3. At Month 6, participants will attend two study visits for repeat baseline measurements. All participants will be contacted by phone every other week during the 6-month treatment period to monitor adverse events and medication compliance.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Statin-naive (i.e., has never taken statins before)

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atorvastatin
80-mg atorvastatin capsules taken daily for 6 months
Placebo
Placebo capsules taken daily for 6 months

Locations

Country Name City State
United States University of Massachusetts Amherst Massachusetts
United States Hartford Hospital Hartford Connecticut
United States University of Connecticut Storrs Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Hartford Hospital National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myopathy frequency Measured every other week
Primary Arm isokinetic force at 60 degrees per second Measured at Month 6
Primary Leg isokinetic force at 60 degrees per second Measured at Month 6
Primary Handgrip isometric force Measured at Month 6
Primary Leg dynamic endurance Measured at Month 6
Primary Maximal aerobic power Measured at Month 6
Secondary Structural differences in the muscle samples obtained from symptomatic and asymptomatic participants Measured after 2 weeks of symptom persistence
Secondary Skeletal muscle gene expression in muscle samples obtained from symptomatic and asymptomatic participants Measured after 2 weeks of symptom persistence
See also
  Status Clinical Trial Phase
Completed NCT00199745 - Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity Phase 4
Completed NCT03979157 - Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles) N/A
Completed NCT04115475 - New Imaging Biomarkers for Muscular Diseases - Multispectral Optoacoustic Imaging in Spinal Muscular Atrophy N/A
Completed NCT03354767 - The Role of Ischaemia-reperfusion Injury in the Pathogenesis of Muscle Wasting After Thoracic Aortic Surgery N/A
Completed NCT03440034 - Study of Pioglitazone in Sporadic Inclusion Body Myositis Phase 1
Completed NCT04838509 - Diagnoses Associated With Persistent Elevation of Creatine Kinase
Completed NCT03406780 - A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy Phase 2
Completed NCT01826487 - Phase 3 Study of Ataluren in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Phase 3
Terminated NCT02090959 - An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy Phase 3
Recruiting NCT05126758 - A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy Phase 3
Recruiting NCT05183152 - Non-invasive BCI-controlled Assistive Devices N/A
Completed NCT03179631 - Long-Term Outcomes of Ataluren in Duchenne Muscular Dystrophy Phase 3
Terminated NCT02829814 - Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia Phase 3
Recruiting NCT06226376 - Mollii Suit and Fibromyalgia (EXOFIB 2) N/A
Completed NCT03250988 - Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility
Completed NCT03211390 - Using Telemedicine to Improve Spasticity Diagnosis Rates
Completed NCT03209960 - Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity
Terminated NCT00240981 - TOM: Testosterone in Older Men With Sarcopenia Phase 4
Completed NCT03268421 - Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia N/A
Completed NCT05730842 - Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers Phase 1