Table 3: TRA 2°P: Time to First Event in Post-MI or PAD Patients without a History of Stroke or TIA Placebo(n=10,090) ZONTIVITY(n=10,080)
Endpoints Patients with events *(%) K-M % Patients with events *(%) K-M %† Hazard Ratio , (95% CI) p-value
*Each patient was counted only once (first component event) in the component summary that contributed to the primary efficacy endpoint.
K-M estimate at 1,080 days.
Hazard ratio is ZONTIVITY group versus placebo group.
Cox proportional hazard model with covariates treatment and stratification factors (qualifying atherosclerotic disease and planned thienopyridine use).
Including patients who could have had other non-fatal events or subsequently died.
In post-MI or PAD patients who survived an on-study efficacy event, the incidence of subsequent events was lower with ZONTIVITY.
The time from the prior MI to randomization had no relationship to the treatment benefit for the primary study outcome.
A range of demographic, concurrent baseline medications, and other treatment differences were examined for their influence on outcomes as shown in Figure 6. Such analyses must be interpreted cautiously, as differences can reflect the play of chance among a large number of analyses.
Figure 6: Subgroup Analyses (Primary Endpoints) of the TRA 2°P Post-MI or PAD Patients without a History of Stroke or TIA
16 HOW SUPPLIED/STORAGE AND HANDLING
ZONTIVITY tablets, 2.08 mg vorapaxar, are yellow, oval-shaped, film-coated tablets with “351″ on one side and the Merck logo on the other side.
They are supplied as follows:
•NDC 0006-0351-31 bottles of 30 tablets
•NDC 0006-0351-54 bottles of 90 tablets
•NDC 0006-0351-48 unit dose packages of 100 tablets (one carton containing 10 10-count blister cards)
permitted between 15-30°C (between 59-86°F). [See USP Controlled Room Temperature.] Store tablets in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture.
Storage of blisters
Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (between 59-86°F). [See USP Controlled Room Temperature.] Store in the original package until use.
PRINCIPAL DISPLAY PANEL — 30 Tablet Bottle Label
NDC 0006-0351-31
Zontivity™
(vorapaxar) tablets
2.08 mg*
Dispense the accompanying
Medication Guide to each patient.
*Each tablet contains 2.08 mg
vorapaxar, equivalent to 2.5 mgvorapaxar sulfate.
Rx only
30 Tablets
ZONTIVITY vorapaxar tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0351
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
vorapaxar sulfate (vorapaxar) vorapaxar 2.08 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
POVIDONES
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15 MPA.S)
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 9mm
Flavor Imprint Code 351
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC |
