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NCT01131104 · ClinicalTrials.gov registry record
A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
A clinical trial, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- 345
- Enrollment target
NCT01131104: Completed study, sponsored by Eli Lilly and Company.
NCT01131104 is a clinical trial that has completed, run by Eli Lilly and Company. The registered enrollment target is 345 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01131104 has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- 345 participants
- Enrollment target
Study Summary
Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.
Primary Outcome
Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
Interventions
- DRUG PDE5 Inhibitors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2010-05 |
| Est. Completion | 2015-12 |
What the finished NCT01131104 record still lists
NCT01131104 is an observational study that tracks outcomes without assigning an intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which PDE5 Inhibitors is the first listed.
NCT01131104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01131104 about?
NCT01131104 is a clinical study titled "A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors". Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjec...
What is the current status of trial NCT01131104?
This trial is currently completed. The enrollment target is 345 participants. The study started on 2010-05. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01131104?
The interventions under investigation include: PDE5 Inhibitors (DRUG).
Who is sponsoring clinical trial NCT01131104?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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