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

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NCT00759174

Last updated on April 7, 2020
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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ischemic Optic Neuropathy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male aged ≥45 years;

- Experienced abrupt visual change in only 1 eye

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic
process or optic neuritis;

- History of NAION or optic neuritis.

- Participation in other studies within 60 days prior to entry in the study.

NCT00759174
Pfizer
Completed
A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

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Descriptive Information
Brief Title A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
Official Title Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION
Brief 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.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Potential cases of acute NAION will be prospectively identified by approximately 125 ophthalmology centers in the US and Europe. Patients must have presented to an ophthalmologist within 3 weeks of symptom onset.
Condition Optic Neuropathy, Ischemic
Intervention Drug: No intervention
No intervention occurs in this observational study.
Study Groups/Cohorts Case Group
Intervention: Drug: No intervention
Publications * Campbell UB, Walker AM, Gaffney M, Petronis KR, Creanga D, Quinn S, Klein BE, Laties AM, Lewis M, Sharlip ID, Kolitsopoulos F, Klee BJ, Mo J, Reynolds RF. Acute nonarteritic anterior ischemic optic neuropathy and exposure to phosphodiesterase type 5 inhibitors. J Sex Med. 2015 Jan;12(1):139-51. doi: 10.1111/jsm.12726. Epub 2014 Oct 31.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2013) 		673
Original Estimated Enrollment
 (submitted: September 22, 2008) 		900
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male aged ?45 years;
  • Experienced abrupt visual change in only 1 eye

Exclusion Criteria:

  • Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
  • History of NAION or optic neuritis.
  • Participation in other studies within 60 days prior to entry in the study.
Sex/Gender
Sexes Eligible for Study: Male
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00759174
Other Study ID Numbers A1481259
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2013

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