Status:
COMPLETED
Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
The TIMI Study Group
Duke Clinical Research Institute
Conditions:
Atherosclerosis
Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04...
Eligibility Criteria
Inclusion
- Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems
Exclusion
- The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
- history or evidence of age-related macular degeneration on baseline evaluation
- history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
- history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
- history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
- history or evidence of glaucoma on baseline evaluation
- history or evidence of high intraocular pressure of \>22 mm Hg on baseline evaluation
- evidence of center foveal thickness of \>190 µm on baseline OCT examination
- presence of vacuoles in the retina on baseline OCT
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00617123
Start Date
July 1 2008
End Date
October 1 2010
Last Update
September 21 2018
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