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

NCT00617123 | Completed Phase 3 Results DMC

• 2 other identifiers: P05183MK-5348-018
• Study Type: interventional
• Target: 258
• Locations: 0 countries
• Sites: N/A

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 (P04737) (NCT00526474).

Conditions

Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)

  Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).

  Up to 12 months

Secondary Outcomes (4)

• Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline

  Baseline and 4, 8 and 12 months

• Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT

  Baseline and 4, 8 and 12 months

• Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT

  Baseline and 4, 8 and 12 months

• Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography

  Baseline and 4, 8 and 12 months

Study Arms (2)

Vorapaxar

EXPERIMENTAL

Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year

Drug: Vorapaxar 2.5 mg

Placebo

PLACEBO COMPARATOR

Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year

Drug: Placebo

Interventions

Vorapaxar 2.5 mg DRUG

Vorapaxar 2.5 mg oral tablet

Vorapaxar

Placebo DRUG

matching placebo oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• The TIMI Study Group: collaborator
• Duke Clinical Research Institute: collaborator

MeSH Terms

Conditions

Atherosclerosis; Ischemia; Myocardial Infarction; Stroke

Interventions

vorapaxar

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Infarction; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 21, 2018
• Results First Posted: July 14, 2014

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share