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HMG-CoA reductase inhibitor
Impact of Statin Therapy on Adaptations to Aerobic Exercise
Phase 4
Waitlist Available
Led By John Thyfault, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
>5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 12
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial will test how different doses of a statin affects muscle health and exercise ability.
Who is the study for?
This trial is for adults at risk of heart disease, with a BMI between 25-43 and leading a sedentary lifestyle. They should have stable medication doses and be willing to pause NSAIDs and aspirin before muscle tests. Those who've had significant weight changes or are very active aren't eligible.
What is being tested?
The study examines how high (80mg) and low (20mg) doses of Lipitor—a cholesterol-lowering drug—alongside an exercise program affect muscle health compared to a placebo in individuals at risk for cardiovascular disease.
What are the potential side effects?
Possible side effects from Lipitor may include muscle pain, fatigue, headache, digestive issues like constipation or diarrhea, and increased liver enzymes which might indicate liver strain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at a high risk for heart disease in the next 10 years or have at least 2 metabolic syndrome risk factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Oxygen Consumption
Secondary study objectives
Citrate synthase activity
Insulin sensitivity
Mitochondrial respiratory function
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Statin & Exercise GroupExperimental Treatment2 Interventions
Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
Group II: High Statin & Exercise GroupExperimental Treatment2 Interventions
Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.
Group III: Placebo & Exercise GroupPlacebo Group2 Interventions
Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipitor 20Mg Tablet
2018
Completed Phase 4
~190
Lipitor 80Mg Tablet
2018
Completed Phase 4
~190
Exercise Program
2016
Completed Phase 4
~5010
Find a Location
Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,899 Total Patients Enrolled
University of Kansas Medical CenterLead Sponsor
517 Previous Clinical Trials
177,322 Total Patients Enrolled
John Thyfault, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
2 Previous Clinical Trials
79 Total Patients Enrolled