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History of Changes for Study: NCT02932410
A Study to Find Out Whether the Medicine Macitentan Works in Children With Pulmonary Arterial Hypertension (PAH) (TOMORROW)
Latest version (submitted November 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 12, 2016 None (earliest Version on record)
2 March 17, 2017 Study Status, Oversight and Outcome Measures
3 April 25, 2017 Study Status and Contacts/Locations
4 June 29, 2017 Study Status, Outcome Measures, Arms and Interventions, Study Identification, Eligibility, Study Description and Oversight
5 July 26, 2017 Study Status
6 August 31, 2017 Recruitment Status, Study Status and Contacts/Locations
7 September 12, 2017 Study Status
8 October 2, 2017 Study Status and Contacts/Locations
9 November 9, 2017 Study Status and Contacts/Locations
10 December 7, 2017 Study Status and Contacts/Locations
11 January 8, 2018 Study Status and Contacts/Locations
12 February 8, 2018 Study Status and Contacts/Locations
13 March 12, 2018 Study Status and Contacts/Locations
14 March 15, 2018 Contacts/Locations and Study Status
15 April 3, 2018 Contacts/Locations and Study Status
16 May 4, 2018 Study Status and Contacts/Locations
17 June 6, 2018 Contacts/Locations and Study Status
18 July 17, 2018 Study Status and Contacts/Locations
19 August 14, 2018 Study Status and Contacts/Locations
20 September 20, 2018 Contacts/Locations and Study Status
21 November 16, 2018 Contacts/Locations and Study Status
22 December 19, 2018 Contacts/Locations and Study Status
23 January 22, 2019 Contacts/Locations and Study Status
24 February 19, 2019 Contacts/Locations and Study Status
25 March 19, 2019 Contacts/Locations and Study Status
26 April 16, 2019 Contacts/Locations and Study Status
27 May 14, 2019 Contacts/Locations and Study Status
28 June 11, 2019 Study Status and Contacts/Locations
29 September 3, 2019 Study Status
30 November 26, 2019 Contacts/Locations and Study Status
31 February 18, 2020 Study Status and Contacts/Locations
32 April 27, 2020 Study Status and Contacts/Locations
33 June 9, 2020 Study Status and Contacts/Locations
34 October 16, 2020 Eligibility, Contacts/Locations and Study Status
35 October 27, 2020 Contacts/Locations and Study Status
36 November 24, 2020 Contacts/Locations and Study Status
37 December 22, 2020 Contacts/Locations and Study Status
38 January 19, 2021 Contacts/Locations and Study Status
39 April 13, 2021 Contacts/Locations and Study Status
40 May 21, 2021 Contacts/Locations and Study Status
41 June 8, 2021 Contacts/Locations and Study Status
42 August 3, 2021 Contacts/Locations and Study Status
43 September 28, 2021 Study Status
44 October 26, 2021 Study Status
45 November 23, 2021 Study Status
46 December 21, 2021 Outcome Measures, Eligibility, Study Status, Arms and Interventions, Study Description and Study Identification
47 February 1, 2022 Contacts/Locations and Study Status
48 March 1, 2022 Study Status
49 March 29, 2022 Contacts/Locations and Study Status
50 April 26, 2022 Study Status
51 June 21, 2022 Contacts/Locations and Study Status
52 July 19, 2022 Study Status
53 August 16, 2022 Contacts/Locations and Study Status
54 September 13, 2022 Study Status
55 October 11, 2022 Contacts/Locations and Study Status
56 November 8, 2022 Contacts/Locations and Study Status
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Study NCT02932410
Submitted Date:  October 12, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: AC-055-312
Brief Title: A Study to Find Out Whether the Medicine Macitentan Works in Children With Pulmonary Arterial Hypertension (PAH) (TOMORROW)
Official Title: TOMORROW: pediaTric Use Of Macitentan tO Delay Disease pRogRessiOn in PAH Worldwide
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2016
Overall Status: Not yet recruiting
Study Start: February 2017
Primary Completion: July 2022 [Anticipated]
Study Completion: July 2022 [Anticipated]
First Submitted: October 12, 2016
First Submitted that
Met QC Criteria:
October 12, 2016
First Posted: October 13, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 12, 2016
Last Update Posted: October 13, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Actelion
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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 Description:
Open or close this module Conditions
Conditions: Pulmonary Arterial Hypertension
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Macitentan
ACT-064992
Drug: Macitentan
Dispersible tablet; Oral use
Standard-of-care
Standard-of-care as per site's clinical practice which may comprise treatment with PAH non-specific treatment and/or up to two PAH-specific medications excluding macitentan and i.v./s.c. prostanoids.
Standard-of-care
Standard-of-care as per site's clinical practice which may comprise treatment with PAH non-specific treatment and/or up to two PAH-specific medications excluding macitentan and i.v./s.c. prostanoids.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Time to the first CEC-confirmed disease progression event
[ Time Frame: Between randomization and EOS/study closure; up to 6 years ]

Time to the first of the following CEC-confirmed disease progression events: • Death (all causes) • Atrial septostomy or Potts' anastomosis, or registration on lung transplant list • Hospitalization due to worsening PAH • Clinical worsening of PAH
Secondary Outcome Measures:
1. 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 ]

2. 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 ]

3. Time to death (all causes) occurring between randomization and Study Closure
[ Time Frame: Between randomization and EOS/study closure; up to 6 years ]

Open or close this module Eligibility
Minimum Age: 2 Years
Maximum Age: 17 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Signed informed consent by the parent(s) or legally designated representative AND assent from developmentally capable children prior to initiation of any study-mandated procedure.
  2. Males or females between ≥ 2 years and < 18 years of age.
  3. Subjects with body weight ≥ 10 kg at randomization.
  4. PAH diagnosis, confirmed by historical RHC (mPAP ≥ 25 mmHg, and PAWP ≤ 15 mmHg, and PVR > 3 WU).
  5. PAH belonging to the Nice 2013 Updated Classification Group 1 (including subjects with Down syndrome) and of following etiologies:
    • iPAH
    • hPAH
    • PAH associated with CHD
    • Drug or toxin induced PAH
    • PAH associated with HIV
    • PAH-aCTD
  6. WHO FC I to III.
  7. Females of childbearing potential must have a negative pregnancy test at Screening and at Baseline, and must agree to undertake monthly pregnancy tests, and to use a reliable method of contraception (if sexually active) up to EOS.

Exclusion Criteria:

  1. Subjects with PAH due to portal hypertension, schistosomiasis, or with pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis, and persistent pulmonary hypertension of the newborn.
  2. Subjects receiving a combination of > 2 PAH-specific treatments at randomization.
  3. Treatment with i.v. or s.c. prostanoids within 4 weeks before randomization, unless given for vasoreactivity testing.
  4. Hemoglobin or hematocrit <75% of the lower limit of normal range
  5. Serum AST and/or ALT > 3 times the upper limit of normal range'
  6. Pregnancy (including family planning) or breastfeeding.
  7. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Open or close this module Contacts/Locations
Central Contact Person: CTD clinical trial disclosure desk
Email: clinical-trials-disclsure@actelion.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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