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Trial record 1 of 1 for:    NCT03345901
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PROMINENT-Eye Ancillary Study (Protocol AD)

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ClinicalTrials.gov Identifier: NCT03345901
Recruitment Status : Terminated (recruitment for the substudy did not meet the goals)
First Posted : November 17, 2017
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Kowa Company, Ltd.
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diabetic Retinopathy
Diabetic Macular Edema
Interventions Drug: Pemafibrate
Drug: Placebo
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enrolled Participants
Hide Arm/Group Description The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
Period Title: Overall Study
Started 18
Completed 0
Not Completed 18
Reason Not Completed
The study was terminated             18
Arm/Group Title Enrolled Participants
Hide Arm/Group Description The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
65
(54 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
5
  27.8%
Male
13
  72.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
1
   5.6%
Not Hispanic or Latino
17
  94.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  16.7%
White
15
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Diabetic Retinopathy Worsening or Diabetic Macular Edema (DME) Development (Composite Outcome)
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated before the participants were randomized or any study visit occurred.
Arm/Group Title Enrolled Participants
Hide Arm/Group Description:
The study was terminated before participants were randomized to an arm. Data include all enrolled participants.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame No adverse event data were collected
Adverse Event Reporting Description The study was terminated and no adverse event data were collected.
 
Arm/Group Title Pemafibrate Placebo
Hide Arm/Group Description

.2 mg pemafibrate orally BID

Pemafibrate: 0.2 mg orally BID - twice daily

Placebo pill orally BID

Placebo: orally BID - twice daily

All-Cause Mortality
Pemafibrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Pemafibrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pemafibrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adam Glassman
Organization: JAEB CENTER FOR HEALTH RESEARCH
Phone: 8139758690
EMail: drcrnet@jaeb.org
Layout table for additonal information
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT03345901    
Other Study ID Numbers: DRCR.net Protocol AD
First Submitted: November 7, 2017
First Posted: November 17, 2017
Results First Submitted: August 27, 2020
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020