Clinical Trials Directory

Trials / Completed

CompletedNCT00759174

A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

Status
Completed
Phase
Study type
Observational
Enrollment
673 (actual)
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
Sex
Male
Age
45 Years
Healthy volunteers
Not accepted

Summary

The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.

Detailed description

Sites will identify patients who meet the entry criteria during the conduct of their normal practice. Patients meeting these criteria will be offered participation in the study after reading and completing an informed consent document.

Conditions

Interventions

TypeNameDescription
DRUGNo interventionNo intervention occurs in this observational study.

Timeline

Start date
2008-11-01
Primary completion
2012-10-01
Completion
2012-10-01
First posted
2008-09-25
Last updated
2021-02-01
Results posted
2013-10-17

Locations

105 sites across 6 countries: United States, France, Germany, Italy, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT00759174. Inclusion in this directory is not an endorsement.