Start Date
June 30, 2020
Primary Completion Date
October 10, 2022
Study Completion Date
October 10, 2022
Brilinta
"Patients in the open-label Run-in period (patients aged 6 to \<24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight \>9 to ≤12 kg) or 15 mg twice a day (body weight \>12 to ≤24 kg) for 14 days.~The double-blind IP will be based on 5 weight bands:~* 6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day~* \>9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day~* \>12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day~* \>24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day~* \>48 kg: ticagrelor 45 mg or matching placebo, twice a day"
Placebo
"Patients in the open-label Run-in period (patients aged 6 to \<24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight \>9 to ≤12 kg) or 15 mg twice a day (body weight \>12 to ≤24 kg) for 14 days.~The double-blind IP will be based on 5 weight bands:~* 6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day~* \>9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day~* \>12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day~* \>24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day~* \>48 kg: ticagrelor 45 mg or matching placebo, twice a day"
Lead Sponsor
Iqvia Pty Ltd
INDUSTRY
AstraZeneca
INDUSTRY