A Phase 4 interventional study of Lipitor 20Mg Tablet and Lipitor 80Mg Tablet in Mitochondrial Diseases, sponsored by University of Kansas Medical Center. Completed at 2 sites in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by University of Kansas Medical Center · Phase 4, Interventional, and Prevention
Among 83 studies in Mitochondrial Diseases with a site in United States — 20 open to participants now, 22 under way, 3 of them phase 3. Mitochondrial Diseases · United States.
Among the 83 studies in Mitochondrial Diseases with a site in United States, this one is the 15th largest by enrollment of the 50 interventional ones that give a count, is one of 7 that started in 2018, is one of 3 in phase 4, and was the 51st registered.
189 studies on the registry are indexed under Mitochondrial Diseases; 60 are open to participants now.
Browse Mitochondrial Diseases studies →20 of the 83 studies in Mitochondrial Diseases with a site in United States are open now. Recruiting first, the newest first:
Pharming Technologies B.V. · Sites in United States, Belgium, Czechia and 6 more countries
Ages 18+
Khondrion BV · Sites in United States, Denmark, France and 4 more countries
Ages 18+
Children's Hospital of Philadelphia · Sites in United States
Ages 8–75 · Healthy volunteers
Children's Hospital of Philadelphia · Sites in United States
Ages 18–65 · Healthy volunteers
University of California, San Diego · Sites in United States
Ages 50+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 40 Mitochondrial Diseases studies recruiting now, 20 (50%) set no upper age limit and 13 (33%) stop at 75 or younger; 19 take children under 18; 17 take healthy volunteers.
This study: 35 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 21 · Phase 3 11 · Phase 4 3
First in 2000; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 68 is above the median of 35 across 114 interventional studies indexed under Mitochondrial Diseases.
Median enrollment 38 across the 50 interventional studies, 61 across the 31 observational. Of the 54 that completed or were terminated, 23 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 83 have an industry lead sponsor. The 10 most frequent:
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.
University of Kansas Medical Center has 1 study filed under Mitochondrial Diseases — fewer than ten, so there is no comparison to draw.
9 of the studies in Mitochondrial Diseases with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05422534Phase 3Vanderbilt University Medical CenterCoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease | 2027-06-20 |
| NCT01803906Columbia UniversityTissue Sample Study for Mitochondrial Disorders | 2026-12 |
| NCT02000284University of ArkansasMitochondrial Dysfunction in Autism Spectrum Disorder | 2026-12-31 |
| NCT01694940Columbia UniversityNorth American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC) | 2026-12-31 |
| NCT03639701Columbia UniversityTreatment of TK2 Deficiency With Thymidine and Deoxycytidine | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 83 studies in Mitochondrial Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle health and function, and cardiovascular fitness.
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.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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 receiving matching placebo oral tablet.
Drug: Placebo Oral Tablet
Participants will receive Lipitor 20Mg Tablet to take daily.
Drug: Lipitor 20Mg Tablet
Participants will receive Lipitor 80Mg Tablet to take daily.
Drug: Lipitor 80Mg Tablet
20 mg/day pills.
Also known as: atorvastatin
80 mg/day pills.
Also known as: atorvastatin
Matching placebo pill.
Also known as: Placebo
Difference in Mitochondrial Respiratory Function
Time frame: value at 12 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 | 23 | 24 | 21 |
| Completed | 16 | 19 | 17 |
| Not completed | 7 | 5 | 4 |
| pmols/s/mg | Placebo | Low Dose Statin | High Dose Statin |
|---|---|---|---|
| Difference in Mitochondrial Respiratory Function | 36 ± 366 | 32 ± 213 | -3 ± 180 |
| L/min | Placebo | Low Dose Statin | High Dose Statin |
|---|---|---|---|
| Change in VO2 Max | -0.2 ± 0.23 | 0.03 ± 0.16 | -0.06 ± 0.18 |
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 | 0/23 (0%) | 1/23 (4.3%) | 15/23 (65.2%) |
| Low Dose Statin | 0/24 (0%) | 0/24 (0%) | 17/24 (70.8%) |
| High Dose Statin | 0/21 (0%) | 0/21 (0%) | 14/21 (66.7%) |
| Event | Placebo | Low Dose Statin | High Dose Statin |
|---|---|---|---|
| Cardiovascular event (SVT) unrelated to interventionCardiac disorders | 1/23 | 0/24 | 0/21 |
| Event | Placebo | Low Dose Statin | High Dose Statin |
|---|---|---|---|
| Muscle or Joint PainMusculoskeletal and connective tissue disorders | 6/23 | 8/24 | 6/21 |
| Adverse event related to testing for studyInvestigations | 2/23 | 5/24 | 2/21 |
| GI UpsetGastrointestinal disorders | 2/23 | 3/24 | 3/21 |
| Sinus Infection/Flu SymptomsRespiratory, thoracic and mediastinal disorders | 0/23 | 3/24 | 3/21 |
| COVID-19Respiratory, thoracic and mediastinal disorders | 3/23 | 3/24 | 0/21 |
| UTIRenal and urinary disorders | 2/23 | 0/24 | 0/21 |
| Age, Continuous(years) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 52.98 ± 8.28 | 54.53 ± 7.66 | 54.10 ± 7.14 | 53.87 ± 7.64 |
| Sex: Female, Male(Participants) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Female | 16 | 17 | 16 | 49 |
| Male | 7 | 7 | 5 | 19 |
| Race (NIH/OMB)(Participants) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 | 6 |
| White | 20 | 23 | 16 | 59 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 2 | 3 |
| Region of Enrollment(participants) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| United States | 23 | 24 | 21 | 68 |
| Total Cholesterol(mg/dL) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 199.65 ± 38.82 | 211.75 ± 41.68 | 214.33 ± 33.53 | 208 ± 38.32 |
| Weight(kg) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 93.79 ± 13.89 | 90.60 ± 15.87 | 89.28 ± 15.22 | 91.27 ± 14.92 |
| BMI(kg/m^2) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 32.96 ± 4.55 | 31.14 ± 3.74 | 32.31 ± 4.98 | 32.12 ± 4.43 |
| Relative Peak VO2 Max(mL/kg/min) | Placebo | Low Dose Statin | High Dose Statin | Total |
|---|---|---|---|---|
| Mean | 24.12 ± 5.7 | 25.53 ± 6.97 | 24.92 ± 5.12 | 24.87 ± 5.96 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Jul 2023, 64 months.
Results were first posted in Dec 2024, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. 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 →