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

Last updated: August 22, 2018
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Stroke

Atherosclerosis

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT00617123
P05183
MK-5348-018
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • The study will include participants who meet none of the exclusion criteria for theparent 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 onbaseline evaluation

  • history or evidence of other retinal diseases, including retinal injury, onbaseline evaluation

  • history or evidence of retinal surgery, including laser photocoagulation, onbaseline evaluation

  • history or evidence of glaucoma on baseline evaluation

  • history or evidence of high intraocular pressure of >22 mm Hg on baselineevaluation

  • evidence of center foveal thickness of >190 µm on baseline OCT examination

  • presence of vacuoles in the retina on baseline OCT

Study Design

Total Participants: 258
Study Start date:
July 01, 2008
Estimated Completion Date:
October 01, 2010