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

This study has been completed.
Sponsor:
Collaborators:
The TIMI (Thrombolysis in Myocardial Infarction) Study Group
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00617123
First received: February 4, 2008
Last updated: July 11, 2014
Last verified: July 2014

February 4, 2008
July 11, 2014
July 2008
October 2010   (final data collection date for primary outcome measure)
Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT) [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
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).
Incidence of vacuolization in the INL of the retina through treatment and follow-up. Vacuolization is defined as the presence of more than one vacuole compared to baseline and will be evaluated by ocular coherence tomography (OCT). [ Time Frame: Through the end of study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00617123 on ClinicalTrials.gov Archive Site
  • Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline [ Time Frame: Baseline and 4, 8 and 12 months ] [ Designated as safety issue: Yes ]
    Visual acuity was assessed in both eyes by best corrected visual acuity following standardized refraction. The best corrected visual acuity score is the number of letters on a standard visual acuity testing chart read correctly by a participant. A decrease in best corrected visual acuity score in the left and/or right eye indicates a worsening of vision.
  • Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT [ Time Frame: Baseline and 4, 8 and 12 months ] [ Designated as safety issue: Yes ]
    Center foveal thickness measured by OCT was evaluated for a change from baseline in greater than 15 microns in either the left or right eye.
  • Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT [ Time Frame: Baseline and 4, 8 and 12 months ] [ Designated as safety issue: Yes ]
    Individual OCT abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 84 (42 possible abnormalities per eye). Data are for the left and right eyes combined (score range: 0 to 84). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.
  • Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography [ Time Frame: Baseline and 4, 8 and 12 months ] [ Designated as safety issue: Yes ]
    Individual fundus photography abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 48 (24 possible abnomalities per eye). Data are for the left and right eyes combined (score range: 0 to 48). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.
Decrease in visual acuity score of at least seven letters from baseline. All visual acuity testing will follow a standardized refraction. [ Time Frame: Through the end of study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study)

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Atherosclerosis
  • Ischemia
  • Myocardial Infarction
  • Cerebrovascular Accident
  • Drug: Vorapaxar 2.5 mg
    Vorapaxar 2.5 mg oral tablet
  • Drug: Placebo
    matching placebo oral tablet
  • Experimental: Vorapaxar
    Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
    Intervention: Drug: Vorapaxar 2.5 mg
  • Placebo Comparator: Placebo
    Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
258
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00617123
P05183, MK-5348-018
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
  • The TIMI (Thrombolysis in Myocardial Infarction) Study Group
  • Duke Clinical Research Institute
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP