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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00759174
First received: September 22, 2008
Last updated: August 8, 2013
Last verified: August 2013
Results First Received: August 8, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Crossover;   Time Perspective: Retrospective
Condition: Optic Neuropathy, Ischemic
Intervention: Drug: No intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Potential NAION Cases With PDE5i Exposure Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
Potential NAION Cases Without PDE5i Exposure Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.

Participant Flow:   Overall Study
    Potential NAION Cases With PDE5i Exposure     Potential NAION Cases Without PDE5i Exposure  
STARTED     76     597  
COMPLETED     76     595  
NOT COMPLETED     0     2  
Unspecified                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Potential NAION Cases With PDE5i Exposure Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
Potential NAION Cases Without PDE5i Exposure Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
Total Total of all reporting groups

Baseline Measures
    Potential NAION Cases With PDE5i Exposure     Potential NAION Cases Without PDE5i Exposure     Total  
Number of Participants  
[units: participants]
  76     597     673  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 7.3     62.3  ± 10.2     62.3  ± 9.9  
Gender  
[units: participants]
     
Female     0     0     0  
Male     76     597     673  



  Outcome Measures
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1.  Primary:   Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases   [ Time Frame: 30-day period prior to onset of NAION symptoms ]

2.  Other Pre-specified:   Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases   [ Time Frame: 30-day period prior to onset of NAION symptoms ]

3.  Other Pre-specified:   Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases   [ Time Frame: 60-day period prior to onset of NAION symptoms ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Potential for bias from inaccuracies in recall of exposure and exposure-based enrollment were evaluated. Although these sources of bias cannot be excluded, they were unlikely to have substantially affected the primary results.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00759174     History of Changes
Other Study ID Numbers: A1481259
Study First Received: September 22, 2008
Results First Received: August 8, 2013
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration