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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 12 months
Awards & highlights

Study Summary

This trial will investigate the effects of different doses of the statin Lipitor on muscle health, function, and cardiovascular fitness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in mitochondrial respiratory function
Secondary outcome measures
Citrate synthase activity
Insulin sensitivity
VO2 max

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
461 Previous Clinical Trials
169,089 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,939 Total Patients Enrolled
John Thyfault, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
2 Previous Clinical Trials
130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate number of individuals participating in this experiment?

"Correct. According to information posted on clinicaltrials.gov, this experimental trial is actively seeking cohorts and was initially published on February 22nd 2018. The study needs 66 individuals from 2 separate locations for successful completion."

Answered by AI

Could you elucidate other experiments that have explored the effects of High dose statin?

"The research into high dose statin began at OHSU Hospital in 2005 and has since completed 633 trials. Presently, 70 investigations are ongoing with Greenville, North carolina being a major source of these studies."

Answered by AI

Does the age cutoff for this medical study include individuals under 80?

"Based on the criteria set forth by this particular medical trial, the participants must be between 35 and 65 years of age. Those younger than 18 or older than sixty-five will find fourteen trials specially designed for them while there are seventy-five options that accommodate those over the age of sixty-five."

Answered by AI

Which demographics are best suited to engage in this research?

"This medical trail is searching for 66 individuals with mitochondrial diseases, between the ages of 35 and 65. Most importantly, applicants must meet a specific BMI range (25-43), maintain weight stability within 5% in the prior 3 months, as well as abstain from consuming Nonsteroidal Antiinflammatory Drugs (NSAIDs) or aspirin 7 days before muscle biopsy."

Answered by AI

Is this endeavor unprecedented in its field?

"Presently, there are 70 active studies related to high dose statin being conducted at 162 cities in 28 countries. The first trial of this kind was held by Merck Sharp & Dohme LLC and completed its final drug approval phase back in 2005 with 80 participants. Since then, 633 further clinical trials have been successfully finished and documented."

Answered by AI

In what circumstances is a high dose of statin typically administered?

"High dose statin therapy can be effective in mitigating the symptoms of lipidemias, postoperative thromboembolism, and anginal pain."

Answered by AI

To what extent is consuming high levels of statin hazardous to one's health?

"Data confirms that high dose statin is safe and approved, resulting in an overall score of 3."

Answered by AI

Are there any vacancies for volunteers in this research endeavor?

"Correct. Information posted on clinicaltrials.gov confirms that recruitment for this research is ongoing, having been initially published February 22nd 2018 and last updated May 2nd 2022. A total of 66 participants are needed to be recruited from two medical facilities."

Answered by AI
~9 spots leftby Apr 2025