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A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors

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ClinicalTrials.gov Identifier: NCT01131104
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Observational
Study Design Observational Model: Case-Crossover;   Time Perspective: Prospective
Condition Nonarteritic Anterior Ischemic Optic Neuropathy
Intervention Drug: PDE5 Inhibitors
Enrollment 345
Recruitment Details  
Pre-assignment Details

Study Set were enrolled participants who met inclusion/exclusion criteria and physician-diagnosed Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)known date of onset.

Adjudication-Confirmed NAION Set were confirmed participants (by adjudication committee) with inclusion/exclusion criteria and physician-diagnosed NAION known date of onset.

Arm/Group Title Enrolled Set
Hide Arm/Group Description Enrolled participants who met inclusion/exclusion criteria and had physician-diagnosed NAION with a known date of onset.
Period Title: Overall Study
Started 345
Study Set 344
Adjudication-Confirmed NAION Set 279
30-Day Analysis Set [1] 24
42-Day Analysis Set [1] 28
12-Month Analysis Set [1] 26
Completed 332
Not Completed 13
Reason Not Completed
Withdrawal by Subject             3
Physician Decision             4
Information Not Available             5
No Information on Index Date of Onset             1
[1]
Participants had adjudication-confirmed NAION and complete PDE5 inhibitor information.
Arm/Group Title Cohort 1
Hide Arm/Group Description Participants with NAION who have used PDE5 inhibitors
Overall Number of Baseline Participants 279
Hide Baseline Analysis Population Description
Participants with adjudication-confirmed NAION.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 279 participants
61.5  (10.70)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants
Female 0
Male 279
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants
American Indian or Alaska Native 0
Asian 2
Native Hawaiian or Other Pacific Islander 1
Black or African American 2
Caucasian 267
More than one race 2
Unknown or Not Reported 5
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants
Hispanic or Latino 11
Not Hispanic or Latino 265
Unknown or Not Reported 3
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 279 participants
279
Adjudicated NAION Participants within the 30-Day Analysis Set  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants
24
1.Primary Outcome
Title 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
Hide Description Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
Time Frame 30 days prior to NAION onset
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the 30 day analysis set.
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Participants with NAION who have used PDE5 inhibitors
Overall Number of Participants Analyzed 24
Overall Number of Units Analyzed
Type of Units Analyzed: Participant days
720
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Relative risk of exposure
2.27
(0.99 to 5.20)
Time Frame [Not Specified]
Adverse Event Reporting Description No serious adverse events or other adverse events were assessed or collected, with the exception of NAION.
 
Arm/Group Title Cohort 1
Hide Arm/Group Description Participants with NAION who have used PDE5 inhibitors.
All-Cause Mortality
Cohort 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1
Affected / at Risk (%)
Total   0/345 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1
Affected / at Risk (%)
Total   0/345 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01131104     History of Changes
Other Study ID Numbers: 11638
H6D-MC-LVHQ ( Other Identifier: Eli Lilly and Company )
First Submitted: May 10, 2010
First Posted: May 26, 2010
Results First Submitted: December 8, 2016
Results First Posted: April 5, 2018
Last Update Posted: April 5, 2018