Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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 (P04737) (NCT00526474).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Duke Clinical Research Institute; The TIMI (Thrombolysis in Myocardial Infarction) Study Group
• Treatments: Vorapaxar

Criteria

Inclusion Criteria:

• Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

Exclusion Criteria:

• 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