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HMG-CoA reductase inhibitor

High dose statin for Mitochondrial Disease

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This study is evaluating whether a common cholesterol lowering medication may help improve muscle health and function.

Eligible Conditions
  • Mitochondrial Disease
  • Mitochondrial Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
Active Control
Placebo Group
Group I: High dose statinActive Control1 Intervention
Participants will receive Lipitor 80Mg Tablet to take daily.
Group II: Low dose statinActive Control1 Intervention
Participants will receive Lipitor 20Mg Tablet to take daily.
Group III: PlaceboPlacebo Group1 Intervention
Participants receiving matching placebo oral tablet.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,827 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,444 Total Patients Enrolled
John Thyfault, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
2 Previous Clinical Trials
130 Total Patients Enrolled
~9 spots leftby Nov 2025
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