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NCT00867815 · ClinicalTrials.gov registry record · Phase 4

PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

A Phase 4 study, sponsored by Bayer.

Terminated
Registry status
Phase 4
Development phase
10
Enrollment target

NCT00867815: Clinical Trial Phase 4 study, sponsored by Bayer.

NCT00867815 is a Phase 4 study that was terminated before completion, run by Bayer. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00867815, a Phase 4 study, was terminated before completion, sponsored by Bayer.

TERMINATED
Registry status
Phase 4
Development phase
10 participants
Enrollment target

Study Summary

The primary objective of this study is to determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.

Primary Outcome

The study population consisted of adult men, first diagnosed with NAION which started within 45 days before study start and took PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) in the 1 year prior to enrollment.

Interventions

  • DRUG Diagnostic procedures

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-07-13
Est. Completion 2018-03-28
Phase Phase 4
Bayer

591 total trials

Why NCT00867815 stopped before completion

NCT00867815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Diagnostic procedures is the first listed.

NCT00867815 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00867815 about?

NCT00867815 is a clinical study titled "PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)". The primary objective of this study is to determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.

What is the current status of trial NCT00867815?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2009-07-13. Estimated completion is 2018-03-28.

What interventions are being tested in trial NCT00867815?

The interventions under investigation include: Diagnostic procedures (DRUG).

Who is sponsoring clinical trial NCT00867815?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00867815's enrollment target sits among peer trials

10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00867815, the US trial registry maintained by the National Library of Medicine. NCT00867815 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.