Trial Outcomes & Findings for Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity (NCT NCT03351998)
NCT ID: NCT03351998
Last Updated: 2024-12-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
68 participants
Primary outcome timeframe
value at 12 months minus value at baseline
Results posted on
2024-12-18
Participant Flow
All 68 participants that were officially enrolled were randomized.
Participant milestones
| Measure |
Placebo
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
Participants will receive Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
Participants will receive Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
21
|
|
Overall Study
COMPLETED
|
16
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
Baseline characteristics by cohort
| Measure |
Placebo
n=23 Participants
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=24 Participants
Participants will receive Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=21 Participants
Participants will receive Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.98 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
54.53 years
STANDARD_DEVIATION 7.66 • n=7 Participants
|
54.10 years
STANDARD_DEVIATION 7.14 • n=5 Participants
|
53.87 years
STANDARD_DEVIATION 7.64 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Total Cholesterol
|
199.65 mg/dL
STANDARD_DEVIATION 38.82 • n=5 Participants
|
211.75 mg/dL
STANDARD_DEVIATION 41.68 • n=7 Participants
|
214.33 mg/dL
STANDARD_DEVIATION 33.53 • n=5 Participants
|
208 mg/dL
STANDARD_DEVIATION 38.32 • n=4 Participants
|
|
Weight
|
93.79 kg
STANDARD_DEVIATION 13.89 • n=5 Participants
|
90.60 kg
STANDARD_DEVIATION 15.87 • n=7 Participants
|
89.28 kg
STANDARD_DEVIATION 15.22 • n=5 Participants
|
91.27 kg
STANDARD_DEVIATION 14.92 • n=4 Participants
|
|
BMI
|
32.96 kg/m^2
STANDARD_DEVIATION 4.55 • n=5 Participants
|
31.14 kg/m^2
STANDARD_DEVIATION 3.74 • n=7 Participants
|
32.31 kg/m^2
STANDARD_DEVIATION 4.98 • n=5 Participants
|
32.12 kg/m^2
STANDARD_DEVIATION 4.43 • n=4 Participants
|
|
Relative Peak VO2 Max
|
24.12 mL/kg/min
STANDARD_DEVIATION 5.7 • n=5 Participants
|
25.53 mL/kg/min
STANDARD_DEVIATION 6.97 • n=7 Participants
|
24.92 mL/kg/min
STANDARD_DEVIATION 5.12 • n=5 Participants
|
24.87 mL/kg/min
STANDARD_DEVIATION 5.96 • n=4 Participants
|
PRIMARY outcome
Timeframe: value at 12 months minus value at baselineOutcome measures
| Measure |
Placebo
n=16 Participants
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=17 Participants
Participants will receive Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=16 Participants
Participants will receive Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Difference in Mitochondrial Respiratory Function
|
36 pmols/s/mg
Standard Deviation 366
|
32 pmols/s/mg
Standard Deviation 213
|
-3 pmols/s/mg
Standard Deviation 180
|
SECONDARY outcome
Timeframe: value at 12 months minus value at baselineOutcome measures
| Measure |
Placebo
n=15 Participants
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=18 Participants
Participants will receive Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=17 Participants
Participants will receive Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Change in VO2 Max
|
-0.2 L/min
Standard Deviation 0.23
|
0.03 L/min
Standard Deviation 0.16
|
-0.06 L/min
Standard Deviation 0.18
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Low Dose Statin
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
High Dose Statin
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=23 participants at risk
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=24 participants at risk
Participants will receive Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=21 participants at risk
Participants will receive Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Cardiac disorders
Cardiovascular event (SVT) unrelated to intervention
|
4.3%
1/23 • Number of events 1 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
0.00%
0/24 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
0.00%
0/21 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
Other adverse events
| Measure |
Placebo
n=23 participants at risk
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=24 participants at risk
Participants will receive Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=21 participants at risk
Participants will receive Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
13.0%
3/23 • Number of events 4 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
12.5%
3/24 • Number of events 3 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
0.00%
0/21 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
|
Renal and urinary disorders
UTI
|
8.7%
2/23 • Number of events 2 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
0.00%
0/24 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
0.00%
0/21 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
GI Upset
|
8.7%
2/23 • Number of events 2 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
12.5%
3/24 • Number of events 3 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
14.3%
3/21 • Number of events 3 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Muscle or Joint Pain
|
26.1%
6/23 • Number of events 6 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
33.3%
8/24 • Number of events 9 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
28.6%
6/21 • Number of events 7 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
|
Investigations
Adverse event related to testing for study
|
8.7%
2/23 • Number of events 2 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
20.8%
5/24 • Number of events 6 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
9.5%
2/21 • Number of events 2 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Infection/Flu Symptoms
|
0.00%
0/23 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
12.5%
3/24 • Number of events 3 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
14.3%
3/21 • Number of events 3 • 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.
The definitions used for adverse events and/or serious adverse events are the same as clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place