Trial Outcomes & Findings for Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy (NCT NCT01280604)
NCT ID: NCT01280604
Last Updated: 2015-06-08
Results Overview
Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
6-10 weeks
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
Intervention
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.
|
Control
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
Subjects Meeting All Inclusion Criteria
|
25
|
29
|
|
Overall Study
COMPLETED
|
24
|
28
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy
Baseline characteristics by cohort
| Measure |
Intervention
n=25 Participants
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.
|
Control
n=29 Participants
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
57.55 years
STANDARD_DEVIATION 9.26 • n=7 Participants
|
57.41 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
29 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-10 weeksTriglyceride levels will be assessed in study participants 6-10 weeks after entry into study.
Outcome measures
| Measure |
Intervention
n=24 Participants
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.
|
Control
n=28 Participants
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
|
|---|---|---|
|
Triglyceride Levels
Baseline Triglyceride Levels
|
135.5 milligram/deciliter
Standard Deviation 36.22
|
108.3 milligram/deciliter
Standard Deviation 37.41
|
|
Triglyceride Levels
Follow-Up Triglyceride Levels
|
152.7 milligram/deciliter
Standard Deviation 42.61
|
109 milligram/deciliter
Standard Deviation 39.70
|
SECONDARY outcome
Timeframe: 6-10 weeksLDL levels will be assessed in study participants 6-10 weeks after entry into study.
Outcome measures
| Measure |
Intervention
n=24 Participants
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.
|
Control
n=28 Participants
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
|
|---|---|---|
|
Low-density Lipoprotein (LDL)
Baseline Low-density lipoprotein
|
95.32 milligram/deciliter
Standard Deviation 21.32
|
83.29 milligram/deciliter
Standard Deviation 22.99
|
|
Low-density Lipoprotein (LDL)
Follow-up Low-density lipoprotein
|
84.42 milligram/deciliter
Standard Deviation 21.05
|
78.71 milligram/deciliter
Standard Deviation 21.93
|
SECONDARY outcome
Timeframe: 6-10 weeksHDL levels will be assessed in study participants 6-10 weeks after entry into study.
Outcome measures
| Measure |
Intervention
n=24 Participants
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.
|
Control
n=28 Participants
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
|
|---|---|---|
|
High-density Lipoprotein,(HDL)
Baseline High-density lipoprotein
|
41.88 milligram/deciliter
Standard Deviation 9.58
|
41.79 milligram/deciliter
Standard Deviation 14.24
|
|
High-density Lipoprotein,(HDL)
Follow-up High-density lipoprotein
|
43.21 milligram/deciliter
Standard Deviation 38.99
|
38.79 milligram/deciliter
Standard Deviation 33.61
|
SECONDARY outcome
Timeframe: 6-10 weeksALT levels will be assessed in study participants 6-10 weeks after entry into study.
Outcome measures
| Measure |
Intervention
n=24 Participants
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.
|
Control
n=28 Participants
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
|
|---|---|---|
|
Alanine Aminotransferase(ALT)
Baseline Alanine aminotransferase
|
29.76 international units/liter
Standard Deviation 26.20
|
30.66 international units/liter
Standard Deviation 26.61
|
|
Alanine Aminotransferase(ALT)
Follow-up Alanine aminotransferase
|
27.38 international units/liter
Standard Deviation 9.13
|
29.96 international units/liter
Standard Deviation 11.03
|
SECONDARY outcome
Timeframe: 6-10 weeksAST levels will be assessed in study participants 6-10 weeks after entry into study.
Outcome measures
| Measure |
Intervention
n=24 Participants
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.
|
Control
n=28 Participants
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
|
|---|---|---|
|
Aspartate Aminotransferase (AST)
Follow-up Aspartate Aminotransferase
|
25.5 international units/liter
Standard Deviation 5.41
|
26.36 international units/liter
Standard Deviation 6.49
|
|
Aspartate Aminotransferase (AST)
Baseline Aspartate Aminotransferase
|
27.48 international units/liter
Standard Deviation 6.14
|
27.59 international units/liter
Standard Deviation 8.57
|
SECONDARY outcome
Timeframe: 6-10 weeksSCr levels will be assessed in study participants 6-10 weeks after entry into study.
Outcome measures
| Measure |
Intervention
n=24 Participants
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.
|
Control
n=28 Participants
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
|
|---|---|---|
|
Serum Creatinine(SCr)
Baseline Serum Creatinine
|
0.9880 milligram/deciliter
Standard Deviation 0.2571
|
1.14 milligram/deciliter
Standard Deviation 0.24
|
|
Serum Creatinine(SCr)
Follow-up Serum Creatinine
|
1 milligram/deciliter
Standard Deviation 0.23
|
1.13 milligram/deciliter
Standard Deviation 0.23
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kendra Manigault, PharmD, BCPS, BCACP, CDE
Mercer University/ Kaiser Permanente
Phone: 678-547-6216
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place