Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03351998|
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : April 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mitochondrial Diseases||Drug: Lipitor 20Mg Tablet Drug: Lipitor 80Mg Tablet Drug: Placebo Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity|
|Actual Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2023|
Placebo Comparator: Placebo
Participants receiving matching placebo oral tablet.
Drug: Placebo Oral Tablet
Matching placebo pill.
Other Name: Placebo
Active Comparator: Low dose statin
Participants will receive Lipitor 20Mg Tablet to take daily.
Drug: Lipitor 20Mg Tablet
20 mg/day pills.
Other Name: atorvastatin
Active Comparator: High dose statin
Participants will receive Lipitor 80Mg Tablet to take daily.
Drug: Lipitor 80Mg Tablet
80 mg/day pills.
Other Name: atorvastatin
- Difference in mitochondrial respiratory function [ Time Frame: 12 Months ]
- VO2 max [ Time Frame: 12 Months ]
- Insulin sensitivity [ Time Frame: 12 Months ]
- Citrate synthase activity [ Time Frame: 12 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351998
|Contact: Clara Amat, MSfirstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|United States, North Carolina|
|East Carolina University||Recruiting|
|Greenville, North Carolina, United States, 27858|
|Contact: Patty Brophy|
|Principal Investigator: Darrell Neufer, PhD|
|Principal Investigator:||John Thyfault, PhD||University of Kansas Medical Center|