A Phase 4 interventional study of Lipitor 20Mg Tablet and Lipitor 80Mg Tablet in Cardiovascular Diseases, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by University of Kansas Medical Center · Phase 4, Interventional, and Prevention
The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.
High cholesterol and cardiovascular disease (CVD) is currently prevented and treated with statin therapy. Statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase with dose and duration of statin use. Statins may also change the ability to exercise.
This study is testing how different doses of a statin, Lipitor, affect muscle health and exercise. The doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol.
This study is expected to last about 14 weeks.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's enrollment of 52 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Weight stable (no more than 5% change in body weight the previous 3 months)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.
Drug: Placebo · Behavioral: Exercise Program
Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
Drug: Lipitor 20Mg Tablet · Behavioral: Exercise Program
Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.
Drug: Lipitor 80Mg Tablet · Behavioral: Exercise Program
One tablet by mouth every day for 12 weeks.
Also known as: Atorvastatin
One tablet by mouth every day for 12 weeks.
Also known as: Atorvastatin
One matching placebo tablet by mouth every day for 12 weeks.
Exercise program of brisk walking and/or slow jogging on a treadmill for 90 minutes of exercise spread over 3 days during week 1, 150 minutes of exercise spread over 5 days during week 2, 225 minutes of exercise over 5 days during week 3 and for the rest of the study.
Difference in Mitochondrial Respiratory Function
Time frame: Value at 3 months minus value at baseline
Change in VO2 Max
Time frame: Value at 12 months minus value at baseline
| Milestone | Placebo | Low Dose Statin | High Dose Statin |
|---|---|---|---|
| Started | 16 | 17 | 19 |
| Completed | 14 | 13 | 16 |
| Not completed | 2 | 4 | 3 |
| pmols/s/mg | Placebo | Low Dose Statin | High Dose Statin |
|---|---|---|---|
| Difference in Mitochondrial Respiratory Function | 2.29 ± 125.59 | -11.24 ± 130.12 | 44.88 ± 105.19 |
| L/min | Placebo | Low Dose Statin | High Dose Statin |
|---|---|---|---|
| Change in VO2 Max | 0.22 ± 0.18 | 0.23 ± 0.21 | 0.21 ± 0.23 |
Collected over Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/16 (0%) | 0/16 (0%) | 3/16 (18.8%) |
| Low Dose Statin | 0/17 (0%) | 0/17 (0%) | 5/17 (29.4%) |
| High Dose Statin | 0/19 (0%) | 0/19 (0%) | 8/19 (42.1%) |
| Event | Placebo | Low Dose Statin | High Dose Statin |
|---|---|---|---|
| Muscle or Joint PainMusculoskeletal and connective tissue disorders | 2/16 | 4/17 | 7/19 |
| Respiratory IllnessRespiratory, thoracic and mediastinal disorders | 0/16 | 0/17 | 2/19 |
| Restless LegsMusculoskeletal and connective tissue disorders | 1/16 | 1/17 | 0/19 |
| Age, Continuous(years) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 50.13 ± 8.29 | 51.28 ± 9.04 | 50.85 ± 7.96 | 50.78 ± 8.28 |
| Sex: Female, Male(Participants) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Female | 12 | 13 | 15 | 40 |
| Male | 4 | 4 | 4 | 12 |
| Race (NIH/OMB)(Participants) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 3 | 4 | 12 |
| White | 10 | 13 | 14 | 37 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| United States | 16 | 17 | 19 | 52 |
| Total Cholesterol(mg/dL) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 200.19 ± 31.63 | 220.33 ± 38.54 | 204.90 ± 32.24 | 208.65 ± 34.72 |
| Weight(kg) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 94.74 ± 16.15 | 103.42 ± 20.06 | 95.83 ± 14.33 | 98.10 ± 17.08 |
| BMI(kg/m^2) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 34.68 ± 4.58 | 35.43 ± 5.14 | 34.55 ± 4.84 | 34.88 ± 4.79 |
| Relative Peak VO2 Max(mL/kg/min) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 25.29 ± 6.21 | 21.30 ± 6.27 | 22.74 ± 5.74 | 22.97 ± 6.15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Jun 2024, 76 months.
Results were first posted in Apr 2025, 10 months after primary completion.
Of 107 non-industry phase 4 interventional studies under Cardiovascular Diseases, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 76. This study's 76 months is above that.
Counting every sponsor, half of 113 studies reached it within 46 months; a quarter within 26 and three quarters within 64.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atorvastatin
University of Kansas Medical Center →