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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00759174 |
Purpose
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.
| Study Type: | Observational |
| Study Design: | Case-Crossover, Retrospective |
| Official Title: | Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION |
| Estimated Enrollment: | 900 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Case Group |
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 117 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A1481259 |
| Study First Received: | September 22, 2008 |
| Last Updated: | January 29, 2010 |
| ClinicalTrials.gov Identifier: | NCT00759174 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Optic Neuropathy Acute NAION PDE5 Inhibitor |
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Eye Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Optic Nerve Diseases Cranial Nerve Diseases Optic Neuropathy, Ischemic |