Trial Outcomes & Findings for LXRA Gene Polymorphisms and Response to Fenofibrate (NCT NCT00644592)
NCT ID: NCT00644592
Last Updated: 2012-06-01
Results Overview
Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects. Natural logs used
TERMINATED
NA
11 participants
week 12 to week 4
2012-06-01
Participant Flow
UF Clinical Research Center. Started March 2008, completed August 2009.
Patients were screened for eligibility.
Participant milestones
| Measure |
1-Fenofibrate Then Placebo
4 weeks of drug at 160 mg orally per day
|
2 Placebo Then Fenofibrate
4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LXRA Gene Polymorphisms and Response to Fenofibrate
Baseline characteristics by cohort
| Measure |
1-Fenofibrate Then Placebo
n=5 Participants
4 weeks of drug at 160 mg orally per day
|
2 Placebo Then Fenofibrate
n=6 Participants
4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
29.2 years
STANDARD_DEVIATION 17.1 • n=93 Participants
|
26.0 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
27.5 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
6 participants
n=4 Participants
|
11 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: week 12 to week 4Population: Intent was to enroll 30 but drug was withdrawn by provider, with only 11 completing both experimental periods
Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects. Natural logs used
Outcome measures
| Measure |
1-Fenofibrate Then Placebo
n=5 Participants
4 weeks of drug at 160 mg orally per day
|
2 Placebo Then Fenofibrate
n=6 Participants
4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
|
|---|---|---|
|
Log(ENA-Period 2 End/ENA Period 1 End)
|
-0.298 Log of Ratio
Standard Deviation 0.31
|
0.178 Log of Ratio
Standard Deviation 0.22
|
Adverse Events
1-Fenofibrate
2 Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1-Fenofibrate
n=11 participants at risk
4 weeks of drug at 160 mg orally per day
|
2 Placebo
n=11 participants at risk
4 weeks of placebo.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal
|
18.2%
2/11 • Number of events 2 • 4 Weeks on Treatment
|
0.00%
0/11 • 4 Weeks on Treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • 4 Weeks on Treatment
|
9.1%
1/11 • Number of events 1 • 4 Weeks on Treatment
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
9.1%
1/11 • Number of events 1 • 4 Weeks on Treatment
|
9.1%
1/11 • Number of events 1 • 4 Weeks on Treatment
|
Additional Information
Reginald F. Frye, PhD, Associate Professor
University of Florida
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place