Trial Outcomes & Findings for PROMINENT-Eye Ancillary Study (Protocol AD) (NCT NCT03345901)
NCT ID: NCT03345901
Last Updated: 2020-09-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
18 participants
Primary outcome timeframe
4 years
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Enrolled Participants
The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Enrolled Participants
The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
|
|---|---|
|
Overall Study
The study was terminated
|
18
|
Baseline Characteristics
PROMINENT-Eye Ancillary Study (Protocol AD)
Baseline characteristics by cohort
| Measure |
Enrolled Participants
n=18 Participants
The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: The study was terminated before the participants were randomized or any study visit occurred.
Outcome measures
Outcome data not reported
Adverse Events
Pemafibrate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place