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A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) (TOMORROW)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macitentan
Standard-of-care
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

1 Month - 17 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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
  • Males or females between greater than or equal to (>=) 1 month and less than (<) 18 years of age
  • Participants with body weight >= 3.5 kilograms (kg) at randomization
  • Pulmonary arterial hypertension (PAH) diagnosis confirmed by historical RHC (mPAP greater than or equal to [>=] 25 millimeters of mercury [mmHg], and Pulmonary artery wedge pressure [PAWP] less than or equal to [<=] 15 mmHg, and Pulmonary vascular resistance index [PVRi] greater than [>] 3 WU × m2), where in the absence of pulmonary vein obstruction and/or significant lung disease PAWP can be replaced by Left atrium pressure [LAP] or Left ventricular end diastolic pressure [LVEDP] (in absence of mitral stenosis) assessed by heart catheterization
  • PAH belonging to the Nice 2013 Updated Classification Group 1 (including participants with Down Syndrome) and of following etiologies: idiopathic PAH; heritable PAH; PAH associated with congenital heart disease (CHD); Drug or toxin induced PAH; PAH associated with HIV; PAH associated with connective tissue diseases (PAH-aCTD); and World health organization (WHO) Functional class I to III
  • 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 the end of study (EOS)

Key Exclusion Criteria:

  • Participants 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
  • Participants with PAH associated with Eisenmenger syndrome, or with moderate to large left-to-right shunts
  • Participants receiving a combination of > 2 PAH-specific treatments at randomization.
  • Treatment with intravenous (IV) or subcutaneous (SC) prostanoids within 4 weeks before randomization, unless given for vasoreactivity testing
  • Hemoglobin or hematocrit <75 percent (%) of the lower limit of normal range
  • Serum Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) greater than (>) 3 times the upper limit of normal range
  • Pregnancy (including family planning) or breastfeeding.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
  • Severe hepatic impairment, for example Child-Pugh Class C
  • Clinical signs of hypotension which in the investigator's judgment would preclude initiation of a PAH-specific therapy
  • Severe renal insufficiency (estimated creatinine clearance <30 mL/min or serum creatinine >221 micro-moles per liter [micro-mol/L])
  • Participants with known diagnosis of bronchopulmonary dysplasia

Sites / Locations

  • Phoenix Childrens Hospital
  • UCLA Children's Heart CenterRecruiting
  • UCSF Medical Center
  • Childrens Hospital ColoradoRecruiting
  • Children's National Medical CenterRecruiting
  • Riley Hospital For ChildrenRecruiting
  • Boston Children's HospitalRecruiting
  • Detroit Medical Center
  • Mayo Clinic - PPDS
  • Children's Heart CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • Columbia University Medical Center - PINRecruiting
  • Duke University Medical CenterRecruiting
  • East Carolina University
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital
  • Nationwide Children's Hospital
  • Texas Children's Hospital
  • Primary Children's Medical Center
  • University of Virginia Health SystemRecruiting
  • Childrens Hospital of Wisconsin
  • Royal Children's Hospital Melbourne - PINRecruiting
  • Lady Cilento Children's HospitalRecruiting
  • Children's Hospital at Westmead
  • Medizinische Universität GrazRecruiting
  • Landes Frauen Und Kinderklinik Linz
  • Medizinische Universitat WienRecruiting
  • Irmandade Da Santa Casa de Misericórdia de São PauloRecruiting
  • Sainte Justine HospitalRecruiting
  • Stollery Children's HospitalRecruiting
  • Beijing Anzhen Hospital of The Capital University of Medical SciencesRecruiting
  • Beijing Children's Hospital,Capital Medical University
  • Fuwai Hospital
  • The Children's Hospital, Zhejiang University school of Medicine
  • Qingdao Women and Children's HospitalRecruiting
  • Childrens Hospital of ShanghaiRecruiting
  • Shanghai Children's Medical CenterRecruiting
  • General Hospital of Shenyang Military Region
  • Wuhan Asia Heart Hospital
  • Fundacion Santa Fe de BogotaRecruiting
  • Centro Medico Imbanaco de Cali SARecruiting
  • HUS Uusi lastensairaala
  • Hôpital de la Timone EnfantsRecruiting
  • Groupe Hospitalier Necker Enfants MaladesRecruiting
  • Hôpital Haut-Lévêque - Hôpital cardiologiqueRecruiting
  • Hôpital Des EnfantsRecruiting
  • Gottsegen Gyorgy Orszagos Kardiologiai IntezetRecruiting
  • Rambam Medical Center - PPDSRecruiting
  • Schneider Children's Medical Center of Israel - PINRecruiting
  • Chaim Sheba Medical Center
  • Seoul National University HospitalRecruiting
  • Severance Hospital Yonsei University Health System - PPDSRecruiting
  • Institut Jantung NegaraRecruiting
  • University Malaya Medical CentreRecruiting
  • Instituto Nacional de PediatríaRecruiting
  • Instituto Nacional de Cardiologia Dr. Ignacio ChavezRecruiting
  • CICUM San MiguelRecruiting
  • Operadora de Hospitales Angeles SA de CV Hospital Angeles LomasRecruiting
  • Unidad de Investigación Clínica En Medicina SCRecruiting
  • Makati Medical Center
  • Philippine Heart CenterRecruiting
  • Szpital Kliniczny im. Karola Jonschera Uniwersytetu Medycznego im. Karola Marcinkowskiego w PoznaniuRecruiting
  • Instytut Pomnik - Centrum Zdrowia DzieckaRecruiting
  • Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-RozwojowyRecruiting
  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa CruzRecruiting
  • Centro Hospitalar E Universitário de Coimbra EPERecruiting
  • Hospital Santa MartaRecruiting
  • Centro Hospitalar de Sao Joao EPERecruiting
  • Research Institute of Complex Cardiovascular PathologyRecruiting
  • GBUZ Children's Hospital named after Bashlyaeva Z.A. MoscowRecruiting
  • Russian National Research Medical University n.a. N.I.PirogovRecruiting
  • Novosibirsk Research Institue of Blood Circulation Pathology n.a. E.N. MeshalkinRecruiting
  • Saint Petersburg State Pediatric Medical AcademyRecruiting
  • Clinical Hospital №1Recruiting
  • Bashkiria State Medical University
  • University of The Free State
  • Inkosi Albert Luthuli Central Hospital
  • Hospital Universitario Vall d'Hebron - PPDS
  • C.H. Regional Reina Sofia
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
  • Ramathibodi Hospital Mahidol University
  • Siriraj Hospital Mahidol University
  • Maharaj Nakorn Chiang Mai Chiang Mai UniversityRecruiting
  • MI Dnipropetrovsk Specialized Clin. Med. Center of Mother and Child n.a. prof. M.F. Rudnev of DRCRecruiting
  • Municipal Institution of Health Care Regional Children's Clinical HospitalRecruiting
  • MI Scientific Practical Medical Center for Children Cardiology and Cardiosurgery of MOH of UkraineRecruiting
  • Hanoi Heart HospitalRecruiting
  • Hanoi Medical University HospitalRecruiting
  • Children's Hospital 1Recruiting
  • Tam Duc HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Macitentan

Standard-of-care

Arm Description

Macitentan is administered once daily via oral route. Children less than (<) 2 years old (y.o.) will be assigned as a cohort to the macitentan group without randomization. The dose will be adjusted to the participant's age (for those < 2 y.o.) or to the participant's body weight (for those greater than or equal to (>=) 2 y.o.). single-arm extension period (SAEP) will start at end of core period (EOCP) visit and ends at end of study (EOS) visit.

Standard-of-care as per site's clinical practice which may comprise treatment with pulmonary arterial hypertension (PAH) non-specific treatment and/or up to two PAH-specific medications excluding macitentan and intravenous/subcutaneous (IV/SC) prostanoids.

Outcomes

Primary Outcome Measures

Participants Greater than or Equal to (>=) 2 Years: Observed Steady-state Trough Plasma Concentration of Macitentan and its Active Metabolite ACT-132577 at Week 12
Observed steady-state trough plasma concentration of macitentan and its active metabolite ACT-132577 will be reported.
Participants Less than (<) 2 Years: Observed Steady-state Trough Plasma Concentration of Macitentan and its Active Metabolite ACT-132577 at Week 4
Observed steady-state trough plasma concentration of macitentan and its active metabolite ACT-132577 will be reported.

Secondary Outcome Measures

Time to the first CEC-confirmed Disease Progression Event
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.
Time to First CEC-confirmed Hospitalization for PAH
Time to first CEC-confirmed hospitalization for PAH occurring between randomization/visit 2 and EOCP.
Time to CEC-confirmed death due to PAH
Time to CEC-confirmed death due to PAH occurring between randomization/visit 2 and EOCP.
Time to death (all causes)
Time to death (all causes) occurring between randomization/visit 2 and EOCP.
The Percentage of Participants with World Health Organization (WHO) Functional Class (FC) I or II versus III or IV
Percentage of participants with WHO FC I or II versus III or IV will be reported.
Change from Baseline to Week 24 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
The quantitation of NT-proBNP plasma levels will be performed and reported.
Change from Baseline to Week 48 in Moderate to Vigorous Physical Activity as Measured by Accelerometry
Change from baseline to Week 48 in moderate to vigorous physical activity as measured by accelerometry will be reported.
Change from Baseline to Week 24 in Tricuspid Annular Plane Systolic Excursion (TAPSE) Measured by Echocardiography
TAPSE is a dimension used to evaluate right ventricle (RV) longitudinal systolic function; it measures the extent of systolic motion of the lateral portion of the tricuspid ring towards the apex.
Change from Baseline to Week 24 in Left Ventricular Eccentricity Index (LVEI) Measured by Echocardiography
For LVEI, left ventricle (LV) internal diameters will be measured and recorded in millimeter (mm) with up to 1 decimal place, using the parasternal short axis view at the level of the papillary muscles.
Change from Baseline to Week 24 in Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) Generic Core Scales Short Form (SF-15)
The PedsQL 4.0 SF-15 is a questionnaire for quality of life assessment which will assess the general physical, emotional, social and school functioning (15 questions). The questionnaires are adapted for different age groups: toddlers (2-4 years of age), young children (5-7 years of age), children (8-12 years of age), and adolescents (13-14 years of age). It is rated on the scale of 0 to 4 where 0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always.

Full Information

First Posted
October 12, 2016
Last Updated
October 10, 2023
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT02932410
Brief Title
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
Acronym
TOMORROW
Official Title
A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
December 23, 2023 (Anticipated)
Study Completion Date
September 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Macitentan
Arm Type
Experimental
Arm Description
Macitentan is administered once daily via oral route. Children less than (<) 2 years old (y.o.) will be assigned as a cohort to the macitentan group without randomization. The dose will be adjusted to the participant's age (for those < 2 y.o.) or to the participant's body weight (for those greater than or equal to (>=) 2 y.o.). single-arm extension period (SAEP) will start at end of core period (EOCP) visit and ends at end of study (EOS) visit.
Arm Title
Standard-of-care
Arm Type
Other
Arm Description
Standard-of-care as per site's clinical practice which may comprise treatment with pulmonary arterial hypertension (PAH) non-specific treatment and/or up to two PAH-specific medications excluding macitentan and intravenous/subcutaneous (IV/SC) prostanoids.
Intervention Type
Drug
Intervention Name(s)
Macitentan
Other Intervention Name(s)
ACT-064992
Intervention Description
Dispersible tablet; Oral use
Intervention Type
Other
Intervention Name(s)
Standard-of-care
Intervention Description
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 IV/SC prostanoids.
Primary Outcome Measure Information:
Title
Participants Greater than or Equal to (>=) 2 Years: Observed Steady-state Trough Plasma Concentration of Macitentan and its Active Metabolite ACT-132577 at Week 12
Description
Observed steady-state trough plasma concentration of macitentan and its active metabolite ACT-132577 will be reported.
Time Frame
Week 12
Title
Participants Less than (<) 2 Years: Observed Steady-state Trough Plasma Concentration of Macitentan and its Active Metabolite ACT-132577 at Week 4
Description
Observed steady-state trough plasma concentration of macitentan and its active metabolite ACT-132577 will be reported.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Time to the first CEC-confirmed Disease Progression Event
Description
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.
Time Frame
Between randomization/visit 2 and end of core study period (EOCP); up to 7 years
Title
Time to First CEC-confirmed Hospitalization for PAH
Description
Time to first CEC-confirmed hospitalization for PAH occurring between randomization/visit 2 and EOCP.
Time Frame
Between randomization/visit 2 and EOCP/; up to 7 years
Title
Time to CEC-confirmed death due to PAH
Description
Time to CEC-confirmed death due to PAH occurring between randomization/visit 2 and EOCP.
Time Frame
Between randomization/visit 2 and EOCP; up to 7 years
Title
Time to death (all causes)
Description
Time to death (all causes) occurring between randomization/visit 2 and EOCP.
Time Frame
Between randomization/visit 2 and EOCP; up to 7 years
Title
The Percentage of Participants with World Health Organization (WHO) Functional Class (FC) I or II versus III or IV
Description
Percentage of participants with WHO FC I or II versus III or IV will be reported.
Time Frame
Week 24
Title
Change from Baseline to Week 24 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Description
The quantitation of NT-proBNP plasma levels will be performed and reported.
Time Frame
Baseline to Week 24
Title
Change from Baseline to Week 48 in Moderate to Vigorous Physical Activity as Measured by Accelerometry
Description
Change from baseline to Week 48 in moderate to vigorous physical activity as measured by accelerometry will be reported.
Time Frame
Baseline to Week 48
Title
Change from Baseline to Week 24 in Tricuspid Annular Plane Systolic Excursion (TAPSE) Measured by Echocardiography
Description
TAPSE is a dimension used to evaluate right ventricle (RV) longitudinal systolic function; it measures the extent of systolic motion of the lateral portion of the tricuspid ring towards the apex.
Time Frame
Baseline to Week 24
Title
Change from Baseline to Week 24 in Left Ventricular Eccentricity Index (LVEI) Measured by Echocardiography
Description
For LVEI, left ventricle (LV) internal diameters will be measured and recorded in millimeter (mm) with up to 1 decimal place, using the parasternal short axis view at the level of the papillary muscles.
Time Frame
Baseline to Week 24
Title
Change from Baseline to Week 24 in Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) Generic Core Scales Short Form (SF-15)
Description
The PedsQL 4.0 SF-15 is a questionnaire for quality of life assessment which will assess the general physical, emotional, social and school functioning (15 questions). The questionnaires are adapted for different age groups: toddlers (2-4 years of age), young children (5-7 years of age), children (8-12 years of age), and adolescents (13-14 years of age). It is rated on the scale of 0 to 4 where 0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Males or females between greater than or equal to (>=) 1 month and less than (<) 18 years of age Participants with body weight >= 3.5 kilograms (kg) at randomization Pulmonary arterial hypertension (PAH) diagnosis confirmed by historical RHC (mPAP greater than or equal to [>=] 25 millimeters of mercury [mmHg], and Pulmonary artery wedge pressure [PAWP] less than or equal to [<=] 15 mmHg, and Pulmonary vascular resistance index [PVRi] greater than [>] 3 WU × m2), where in the absence of pulmonary vein obstruction and/or significant lung disease PAWP can be replaced by Left atrium pressure [LAP] or Left ventricular end diastolic pressure [LVEDP] (in absence of mitral stenosis) assessed by heart catheterization PAH belonging to the Nice 2013 Updated Classification Group 1 (including participants with Down Syndrome) and of following etiologies: idiopathic PAH; heritable PAH; PAH associated with congenital heart disease (CHD); Drug or toxin induced PAH; PAH associated with HIV; PAH associated with connective tissue diseases (PAH-aCTD); and World health organization (WHO) Functional class I to III 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 the end of study (EOS) Key Exclusion Criteria: Participants 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 Participants with PAH associated with Eisenmenger syndrome, or with moderate to large left-to-right shunts Participants receiving a combination of > 2 PAH-specific treatments at randomization. Treatment with intravenous (IV) or subcutaneous (SC) prostanoids within 4 weeks before randomization, unless given for vasoreactivity testing Hemoglobin or hematocrit <75 percent (%) of the lower limit of normal range Serum Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) greater than (>) 3 times the upper limit of normal range Pregnancy (including family planning) or breastfeeding. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol Severe hepatic impairment, for example Child-Pugh Class C Clinical signs of hypotension which in the investigator's judgment would preclude initiation of a PAH-specific therapy Severe renal insufficiency (estimated creatinine clearance <30 mL/min or serum creatinine >221 micro-moles per liter [micro-mol/L]) Participants with known diagnosis of bronchopulmonary dysplasia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
JNJ.CT@sylogent.com
Facility Information:
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Completed
Facility Name
UCLA Children's Heart Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
310-825-4321
Email
jalejos@mednet.ucla.edu
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-2202
Country
United States
Individual Site Status
Completed
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
720-777-8229
Email
Dunbar.ivy@childrenscolorado.org
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
202-476-5000
Email
jberger@cnmc.org
Facility Name
Riley Hospital For Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
317-948-7152
Email
gsmontgo@iu.edu
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
617-355-7866
Email
mary.mullen@cardio.chboston.org
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Completed
Facility Name
Mayo Clinic - PPDS
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Completed
Facility Name
Children's Heart Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
702-732-1290
Email
arothman@childrensheartcenter.com
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
718-920-2183
Email
nsutton@montefiore.org
Facility Name
Columbia University Medical Center - PIN
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
212-305-4436
Email
usk1@cumc.columbia.edu
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
919-668-8305
Email
kevin.hill@duke.edu
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Completed
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
513-636-7072
Email
russel.hirsch@cchmc.org
Facility Name
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Completed
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Completed
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Completed
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Completed
Facility Name
Royal Children's Hospital Melbourne - PIN
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+61393455718
Email
robert.weintraub@rch.org.au
Facility Name
Lady Cilento Children's Hospital
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+61730682790
Email
Scott.Fox@health.qld.gov.au
Facility Name
Children's Hospital at Westmead
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Completed
Facility Name
Medizinische Universität Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+4331638582677
Email
andreas.gamillscheg@klinikum-graz.at
Facility Name
Landes Frauen Und Kinderklinik Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Completed
Facility Name
Medizinische Universitat Wien
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+4314040031990
Email
sulaima.albinni@meduniwien.ac.at
Facility Name
Irmandade Da Santa Casa de Misericórdia de São Paulo
City
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sainte Justine Hospital
City
Montreal
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Stollery Children's Hospital
City
Toronto
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Beijing Anzhen Hospital of The Capital University of Medical Sciences
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
(860) 106-4212
Ext
431
Email
koko_gu@hotmail.com
Facility Name
Beijing Children's Hospital,Capital Medical University
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Withdrawn
Facility Name
Fuwai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Withdrawn
Facility Name
The Children's Hospital, Zhejiang University school of Medicine
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Withdrawn
Facility Name
Qingdao Women and Children's Hospital
City
Qingdao
ZIP/Postal Code
26600
Country
China
Individual Site Status
Recruiting
Facility Name
Childrens Hospital of Shanghai
City
Shanghai
ZIP/Postal Code
200062
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Children's Medical Center
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+86 21 3862 6161,
Email
xuzhuoming@scmc.com.cn
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang
ZIP/Postal Code
110015
Country
China
Individual Site Status
Withdrawn
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
ZIP/Postal Code
430015
Country
China
Individual Site Status
Withdrawn
Facility Name
Fundacion Santa Fe de Bogota
City
Bogota
ZIP/Postal Code
220246
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro Medico Imbanaco de Cali SA
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Individual Site Status
Recruiting
Facility Name
HUS Uusi lastensairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Completed
Facility Name
Hôpital de la Timone Enfants
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+33491386750
Email
caroline.ovaert@ap-hm.fr
Facility Name
Groupe Hospitalier Necker Enfants Malades
City
Paris cedex 15
ZIP/Postal Code
75743
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+33144494344
Email
damien.bonnet@nck.aphp.fr
Facility Name
Hôpital Haut-Lévêque - Hôpital cardiologique
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+33557656465
Email
xavier.iriart@chu-bordeaux.fr
Facility Name
Hôpital Des Enfants
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+33534558596
Email
dulac.y@chu-toulouse.fr
Facility Name
Gottsegen Gyorgy Orszagos Kardiologiai Intezet
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+36703820305
Email
ablonczyl@gmail.com
Facility Name
Rambam Medical Center - PPDS
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+97248542784
Email
l_bentur@rambam.health.gov.il
Facility Name
Schneider Children's Medical Center of Israel - PIN
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+972504057131
Email
EBirk@clalit.org.il
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Completed
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+82220720266
Email
ped9526@snu.ac.kr
Facility Name
Severance Hospital Yonsei University Health System - PPDS
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+82222288470
Email
jwjung@yuhs.ac
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Pediatría
City
Ciudad De México
ZIP/Postal Code
04530
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+523315220008
Email
lauracreyes2000@gmail.com
Facility Name
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
City
Ciudad De México
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
CICUM San Miguel
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+523333364245
Email
jorge.eduardo.rosas@hotmail.com
Facility Name
Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
City
Mexico
ZIP/Postal Code
52763
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+525552153061
Email
humgaa@yahoo.com
Facility Name
Unidad de Investigación Clínica En Medicina SC
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+528181430795t105
Email
alicia.ramirez@udicem.org
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Individual Site Status
Completed
Facility Name
Philippine Heart Center
City
Quezon City
ZIP/Postal Code
0850
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+6329252401
Email
drjjbalderas@ymail.com
Facility Name
Szpital Kliniczny im. Karola Jonschera Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznań
ZIP/Postal Code
60-572
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+48618491448
Email
rsurmacz@ump.edu.pl
Facility Name
Instytut Pomnik - Centrum Zdrowia Dziecka
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
48228157329
Email
m.zuk@ipczd.pl
Facility Name
Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-Rozwojowy
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+48713270140
Email
malgorzata.ras@gmail.com
Facility Name
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz
City
Carnaxide
ZIP/Postal Code
2790-134
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+351210433170
Email
gnogueirasantos@gmail.com
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+351239483755
Email
marinhosilva1@gmail.com
Facility Name
Hospital Santa Marta
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+351213594332
Email
fatima.pinto@chlc.min-saude.pt
Facility Name
Centro Hospitalar de Sao Joao EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+351220919004
Email
mariajoaobaptista02@gmail.com
Facility Name
Research Institute of Complex Cardiovascular Pathology
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+79043780533
Email
zverevat25@mail.ru
Facility Name
GBUZ Children's Hospital named after Bashlyaeva Z.A. Moscow
City
Moscow
ZIP/Postal Code
125408
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Russian National Research Medical University n.a. N.I.Pirogov
City
Moscow
ZIP/Postal Code
125412
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+74954832101
Email
kovalev@pedklin.ru
Facility Name
Novosibirsk Research Institue of Blood Circulation Pathology n.a. E.N. Meshalkin
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+73833322353
Facility Name
Saint Petersburg State Pediatric Medical Academy
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+78122454623
Email
dr.galustyan@gmail.com
Facility Name
Clinical Hospital №1
City
Tyumen
ZIP/Postal Code
625023
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+7 3452 294487
Email
gorbatikovj@mail.ru
Facility Name
Bashkiria State Medical University
City
Ufa
ZIP/Postal Code
450000
Country
Russian Federation
Individual Site Status
Completed
Facility Name
University of The Free State
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Individual Site Status
Completed
Facility Name
Inkosi Albert Luthuli Central Hospital
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Completed
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Completed
Facility Name
C.H. Regional Reina Sofia
City
Cordoba
ZIP/Postal Code
14001
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+0034915868292
Email
alexrodriguezog@hotmail.com
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+34961244453
Email
carrasco_jim@hotmail.com
Facility Name
Ramathibodi Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Maharaj Nakorn Chiang Mai Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
MI Dnipropetrovsk Specialized Clin. Med. Center of Mother and Child n.a. prof. M.F. Rudnev of DRC
City
Dnipro
ZIP/Postal Code
49000
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+380675671199
Email
igor_makedonsky@yahoo.com
Facility Name
Municipal Institution of Health Care Regional Children's Clinical Hospital
City
Kharkiv
ZIP/Postal Code
61093
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+380573724477
Email
margarytagonchar@gmail.com
Facility Name
MI Scientific Practical Medical Center for Children Cardiology and Cardiosurgery of MOH of Ukraine
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+380677996331
Email
lillit@ukr.net
Facility Name
Hanoi Heart Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+84913008042
Email
ngavuq@gmail.com
Facility Name
Hanoi Medical University Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+84903439809
Email
Quyen_hieu@yahoo.com
Facility Name
Children's Hospital 1
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+84907333288
Email
duocgiang@gmail.com
Facility Name
Tam Duc Hospital
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
+84903928982
Email
phamnguyenvinh@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

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