Trial Outcomes & Findings for A Study Comparing CoQ10 Levels While Taking 3 Different Statins (NCT NCT01660191)
NCT ID: NCT01660191
Last Updated: 2017-01-18
Results Overview
Change in levels will be measured by taking difference between Baseline and Week 12 measures.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
134 participants
Primary outcome timeframe
Change from Baseline to 12 Weeks
Results posted on
2017-01-18
Participant Flow
Participant milestones
| Measure |
Atorvastatin 20mg
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
|---|---|---|---|
|
Enrollment and Washout
STARTED
|
45
|
45
|
44
|
|
Enrollment and Washout
COMPLETED
|
45
|
45
|
44
|
|
Enrollment and Washout
NOT COMPLETED
|
0
|
0
|
0
|
|
Randomization
STARTED
|
45
|
45
|
44
|
|
Randomization
COMPLETED
|
45
|
45
|
44
|
|
Randomization
NOT COMPLETED
|
0
|
0
|
0
|
|
End of Treatment
STARTED
|
45
|
45
|
44
|
|
End of Treatment
COMPLETED
|
44
|
39
|
43
|
|
End of Treatment
NOT COMPLETED
|
1
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing CoQ10 Levels While Taking 3 Different Statins
Baseline characteristics by cohort
| Measure |
Atorvastatin 20mg
n=45 Participants
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
n=45 Participants
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
n=44 Participants
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.68 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
56.66 years
STANDARD_DEVIATION 9.93 • n=7 Participants
|
56.08 years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
55.80 years
STANDARD_DEVIATION 11.57 • n=4 Participants
|
|
Gender
Female
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Gender
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
44 participants
n=5 Participants
|
134 participants
n=4 Participants
|
|
Waist Size
|
36.41 inches
STANDARD_DEVIATION 5.76 • n=5 Participants
|
37.45 inches
STANDARD_DEVIATION 4.20 • n=7 Participants
|
34.54 inches
STANDARD_DEVIATION 5.60 • n=5 Participants
|
36.12 inches
STANDARD_DEVIATION 5.33 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 12 WeeksChange in levels will be measured by taking difference between Baseline and Week 12 measures.
Outcome measures
| Measure |
Atorvastatin 20mg
n=42 Participants
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
n=40 Participants
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
n=36 Participants
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
|---|---|---|---|
|
Changes in Plasma CoQ10 Levels
Ubiquinone
|
-96.70 μg/g
Standard Deviation 224.24
|
-110.42 μg/g
Standard Deviation 136.29
|
-103.91 μg/g
Standard Deviation 237.27
|
|
Changes in Plasma CoQ10 Levels
Total CoQ10
|
-721.09 μg/g
Standard Deviation 830.47
|
-464.85 μg/g
Standard Deviation 571.37
|
-642.43 μg/g
Standard Deviation 874.99
|
|
Changes in Plasma CoQ10 Levels
Upiquinol
|
-624.39 μg/g
Standard Deviation 669.45
|
-354.43 μg/g
Standard Deviation 544.42
|
-538.52 μg/g
Standard Deviation 709.53
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 WeeksChange in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.
Outcome measures
| Measure |
Atorvastatin 20mg
n=44 Participants
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
n=43 Participants
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
n=37 Participants
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
|---|---|---|---|
|
Changes in Major Lipid Parameters - VLDL Size
|
0.68 nanometre (nm)
Standard Deviation 5.63
|
0.81 nanometre (nm)
Standard Deviation 5.84
|
3.17 nanometre (nm)
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksChange in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.
Outcome measures
| Measure |
Atorvastatin 20mg
n=44 Participants
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
n=42 Participants
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
n=37 Participants
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
|---|---|---|---|
|
Changes to Glucose Metabolism - HbA1c and Insulin
HbA1c
|
0.00 percentage change from baseline measure
Standard Deviation 0.03
|
0.00 percentage change from baseline measure
Standard Deviation 0.04
|
0.00 percentage change from baseline measure
Standard Deviation 0.04
|
|
Changes to Glucose Metabolism - HbA1c and Insulin
Insulin
|
0.16 percentage change from baseline measure
Standard Deviation 0.47
|
0.01 percentage change from baseline measure
Standard Deviation 0.43
|
0.17 percentage change from baseline measure
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 WeeksChange in levels will be measured by difference in levels at 12 weeks
Outcome measures
| Measure |
Atorvastatin 20mg
n=42 Participants
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
n=43 Participants
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
n=36 Participants
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
|---|---|---|---|
|
Changes in HDL and LDL Size
HDL Size
|
0.23 nanometre (nm)
Standard Deviation 0.27
|
0.23 nanometre (nm)
Standard Deviation 0.26
|
0.12 nanometre (nm)
Standard Deviation 0.32
|
|
Changes in HDL and LDL Size
LDL Size
|
-0.02 nanometre (nm)
Standard Deviation 0.44
|
-0.11 nanometre (nm)
Standard Deviation 0.43
|
-0.09 nanometre (nm)
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksChange in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.
Outcome measures
| Measure |
Atorvastatin 20mg
n=33 Participants
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
n=30 Participants
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
n=27 Participants
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
|---|---|---|---|
|
Changes to Glucose Metabolism - Fructosamine
|
1.91 µmol
Standard Deviation 17.16
|
-1.17 µmol
Standard Deviation 13.74
|
-3.07 µmol
Standard Deviation 14.77
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 WeeksChange in levels will be measured by difference in levels at 12 weeks.
Outcome measures
| Measure |
Atorvastatin 20mg
n=42 Participants
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
n=43 Participants
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
n=36 Participants
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
|---|---|---|---|
|
Changes HDL Particle Number and LDL Particle Number
HDL Particle Number
|
0.64 particle number
Standard Deviation 5.24
|
2.55 particle number
Standard Deviation 4.19
|
2.05 particle number
Standard Deviation 5.17
|
|
Changes HDL Particle Number and LDL Particle Number
LDL Particle Number
|
-873.48 particle number
Standard Deviation 353.76
|
-768.26 particle number
Standard Deviation 334.01
|
-626.61 particle number
Standard Deviation 341.28
|
Adverse Events
Atorvastatin 20mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pitavastatin 4mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Rosuvastatin 5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atorvastatin 20mg
n=45 participants at risk
Atorvastatin 20mg, once daily by mouth for 12 weeks
|
Pitavastatin 4mg
n=45 participants at risk
Pitavastatin 4mg, once daily by mouth for 12 weeks
|
Rosuvastatin 5 mg
n=44 participants at risk
Rosuvastatin 5mg, once daily by mouth for 12 weeks
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45
|
4.4%
2/45
|
11.4%
5/44
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place