Clinical Trial: A Study to Find Out Whether the Medicine Macitentan Works in Children With Pulmonary Arterial Hypertension (PAH)
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: TOMORROW: pediaTric Use Of Macitentan tO Delay Disease pRogRessiOn in PAH Worldwide
Brief Summary: This is a prospective, multicenter, open-label, randomized, controlled, parallel group, group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and PK of macitentan in children.
Detailed Summary:
Sponsor: Actelion
Current Primary Outcome: Time to the first CEC-confirmed disease progression event [ Time Frame: Between randomization and EOS/study closure; up to 6 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to first CEC-confirmed hospitalization for PAH occurring between randomization and EOS [ Time Frame: Between randomization and EOS/study closure; up to 6 years ]Time to first CEC-confirmed hospitalization for PAH occurring between randomization and EOS
- Time to CEC-confirmed death due to PAH occurring between randomization and EOS [ Time Frame: Between randomization and EOS/study closure; up to 6 years ]Time to CEC-confirmed death due to PAH occurring between randomization and EOS
- Time to death (all causes) occurring between randomization and Study Closure [ Time Frame: Between randomization and EOS/study closure; up to 6 years ]Time to death (all causes) occurring between randomization and Study Closure
Original Secondary Outcome:
- Time to first CEC-confirmed hospitalization for PAH occurring between randomization and EOS [ Time Frame: Between randomization and EOS/study closure; up to 6 years ]
- Time to CEC-confirmed death due to PAH occurring between randomization and EOS [ Time Frame: Between randomization and EOS/study closure; up to 6 years ]
- Time to death (all causes) occurring between randomization and Study Closure [ Time Frame: Between randomization and EOS/study closure; up to 6 years ]
Information By: Actelion
Dates:
Date Received: October 12, 2016
Date Started: July 30, 2017
Date Completion: July 1, 2022
Last Updated: April 25, 2017
Last Verified: April 2017