A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00759174
First received: September 22, 2008
Last updated: November 5, 2012
Last verified: November 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Optic Neuropathy, Ischemic |
Drug: No intervention |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Retrospective |
| Official Title: | Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Acute NAION is the sole endpoint of interest in this study. [ Time Frame: 2 months prior to study entry ] [ Designated as safety issue: Yes ]
| Enrollment: | 674 |
| Study Start Date: | November 2008 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Case Group |
Drug: No intervention
No intervention occurs in this observational study.
|
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.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| 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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759174
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36606 | |
| United States, Alaska | |
| Pfizer Investigational Site | |
| Anchorage, Alaska, United States, 99501 | |
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72205-7199 | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72212 | |
| United States, California | |
| Pfizer Investigational Site | |
| Loma Linda, California, United States, 92354 | |
| Pfizer Investigational Site | |
| Long Beach, California, United States, 90813 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90095 | |
| Pfizer Investigational Site | |
| Oceanside, California, United States, 92056 | |
| Pfizer Investigational Site | |
| Pasadena, California, United States, 91105 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06510 | |
| Pfizer Investigational Site | |
| Southbury, Connecticut, United States, 06488 | |
| Pfizer Investigational Site | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20007 | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Bradenton, Florida, United States, 34208 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33136 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30322 | |
| Pfizer Investigational Site | |
| Augusta, Georgia, United States, 30909 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Lisle, Illinois, United States, 60532 | |
| United States, Iowa | |
| Pfizer Investigational Site | |
| Dubuque, Iowa, United States, 52002 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Prairie Village, Kansas, United States, 66208 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Lafayette, Louisiana, United States, 70503 | |
| Pfizer Investigational Site | |
| Lafayette, Louisiana, United States, 70506 | |
| Pfizer Investigational Site | |
| Ruston, Louisiana, United States, 71270 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21204 | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Beverly, Massachusetts, United States, 01915 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| Pfizer Investigational Site | |
| North Dartmouth, Massachusetts, United States, 02747 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States, 48105 | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Reno, Nevada, United States, 89502 | |
| United States, New Hampshire | |
| Pfizer Investigational Site | |
| Lebanon, New Hampshire, United States, 03756 | |
| Pfizer Investigational Site | |
| Manchester, New Hampshire, United States, 03104 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Chester, New Jersey, United States, 07930 | |
| Pfizer Investigational Site | |
| Newark, New Jersey, United States, 07103 | |
| Pfizer Investigational Site | |
| Roseland, New Jersey, United States, 07068 | |
| Pfizer Investigational Site | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Latham, New York, United States, 12110 | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14642 | |
| Pfizer Investigational Site | |
| Stony Brook, New York, United States, 11794 | |
| Pfizer Investigational Site | |
| Troy, New York, United States, 12180 | |
| Pfizer Investigational Site | |
| Woodbury, New York, United States, 11788 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45242 | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43215 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Lancaster, Pennsylvania, United States, 17602 | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19114 | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29425 | |
| Pfizer Investigational Site | |
| Greenville, South Carolina, United States, 29615 | |
| Pfizer Investigational Site | |
| Spartanburg, South Carolina, United States, 29302 | |
| Pfizer Investigational Site | |
| Spartanburg, South Carolina, United States, 29306 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78705 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23226 | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98104 | |
| France | |
| Pfizer Investigational Site | |
| Angers, Cedex 09, France, 49933 | |
| Pfizer Investigational Site | |
| Amiens, France, 80000 | |
| Pfizer Investigational Site | |
| Dijon Cedex, France, 21033 | |
| Pfizer Investigational Site | |
| Grenoble, France, 38043 | |
| Pfizer Investigational Site | |
| Nantes, France, 44000 | |
| Pfizer Investigational Site | |
| Paris, France, 75012 | |
| Pfizer Investigational Site | |
| Paris Cedex 19, France, 75940 | |
| Pfizer Investigational Site | |
| Strasbourg Cedex, France, 67091 | |
| Germany | |
| Pfizer Investigational Site | |
| Berlin, Germany, 13353 | |
| Pfizer Investigational Site | |
| Frankfurt am Main, Germany, 60590 | |
| Pfizer Investigational Site | |
| Freiburg, Germany, 79106 | |
| Pfizer Investigational Site | |
| Hamburg, Germany | |
| Pfizer Investigational Site | |
| Karlsruhe, Germany, 76133 | |
| Pfizer Investigational Site | |
| Ludwigshafen, Germany, 67063 | |
| Pfizer Investigational Site | |
| Mainz, Germany, 55131 | |
| Pfizer Investigational Site | |
| Munchen, Germany, 81675 | |
| Pfizer Investigational Site | |
| Münster, Germany, 48149 | |
| Pfizer Investigational Site | |
| Tübingen, Germany, 72076 | |
| Italy | |
| Pfizer Investigational Site | |
| Bari, Italy, 70124 | |
| Pfizer Investigational Site | |
| Bologna, Italy, 40138 | |
| Pfizer Investigational Site | |
| Firenze, Italy, 50134 | |
| Pfizer Investigational Site | |
| Messina, Italy, 98124 | |
| Pfizer Investigational Site | |
| Parma, Italy, 43100 | |
| Pfizer Investigational Site | |
| Rome, Italy, 00133 | |
| Pfizer Investigational Site | |
| Torino, Italy, 10122 | |
| Spain | |
| Pfizer Investigational Site | |
| Alcala de Henares, Madrid, Spain, 28805 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08206 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08907 | |
| Pfizer Investigational Site | |
| Cosalada, Spain, 28822 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28034 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28010 | |
| Pfizer Investigational Site | |
| Torrevieja, Spain, 03186 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46009 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Liverpool, United Kingdom, L7 8XP | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M13 9WH | |
| Pfizer Investigational Site | |
| Scarborough, United Kingdom, YO12 6QL | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00759174 History of Changes |
| Other Study ID Numbers: | A1481259 |
| Study First Received: | September 22, 2008 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Optic Neuropathy Acute NAION PDE5 Inhibitor |
Additional relevant MeSH terms:
|
Optic Nerve Diseases Optic Neuropathy, Ischemic Cranial Nerve Diseases Nervous System Diseases Eye Diseases Vascular Diseases |
Cardiovascular Diseases Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013