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Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension (FUTURE 3)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bosentan
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring pulmonary arterial hypertension, children, pediatric, bosentan

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. PAH diagnosis confirmed with right heart catheterization (RHC):

    • Idiopathic or heritable PAH, or
    • Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery) or
    • PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary shunts (after global amendment dated 09 May 2012)
  2. World Health Organization functional Class (WHO FC) I, II or III
  3. Male or female ≥ 3 months and < 12 years of age (maximum age at randomization is 11.5 years)
  4. Body weight ≥ 3.5 kg
  5. Peripheral oxygen saturation (SpO2) ≥ 88% (at rest, on room air)
  6. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase type-5 inhibitor) if present, has to be stable for at least 3 months prior to screening. During the study, all background treatments should remain stable
  7. Signed informed consent by the parents or legal representatives

Exclusion Criteria:

  1. PAH etiologies other than listed above
  2. Non-stable disease status
  3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost
  4. Systolic blood pressure < 80% of the lower limit of normal range
  5. Aspartate aminotransferase and/or alanine aminotransferase values > 1.5 times the upper limit of normal range.
  6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
  7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
  8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet

  9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest:

    • Glibenclamide (glyburide)
    • Cyclosporin A
    • Sirolimus
    • Tacrolimus
    • Fluconazole
    • Rifampicin (rifampin)
    • Ritonavir
    • Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole)
    • Endothelin receptor antagonists (ERAs) other than bosentan
  10. Treatment with another investigational drug within 1 month prior to randomization or planned treatment

Sites / Locations

  • The Children's Hospital - Site 9102
  • Children's National Medical Center - Site 9104
  • Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101
  • Texas Children's Hospital - Department of Cardiology - Site 9107
  • Seattle Children's Hospital - Site 9106
  • Royal Children's Hospital Melbourne, Cardiology - Site 5001
  • The Republican Scientific-Practical Center "Cardiology" - Site 3001
  • Beijing Anzhen Hospital, Capital Medical University- Department of Pediatric Cardiology - Site 5103
  • Cardiovascular Institute and Fuwai Hospital
  • West China 2nd university Hospital-Center of interventional diagnosis and therapy for Children's cardiovascular disease - Site 5104
  • Guangdong General Hospital - Site 5105
  • Shanghai Children's Medical Center - Site 5102
  • Shanghai Pulmonary Hospital, Department of Pulmonary Circulation - Site 5101
  • Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301
  • Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201
  • CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202
  • Deutsches Herzzentrum Kinderkardiologie - Site 1401
  • Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404
  • Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403
  • Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401
  • Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402
  • CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302
  • Indraprashta Apollo Hospitals, Pediatric Cardiology - Site 5303
  • Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101
  • Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501
  • Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502
  • Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401
  • Unidad de Investigacion Clinica en Medicina, SC (UDICEM) - Site 8402
  • Universitair Medish Centrum Groningen, Kindercardiologie - Site 1601
  • Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604
  • Instytut Centrum Zdrowia Matki Polki Klinika Kardiologii ICMP w Lodz - Site 3602
  • Instytut Pomnik - Centrum Zdrowia Dziecka Klinika Kardiologii Dziecięcej - Site 3601
  • Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605
  • RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805
  • Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803
  • Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804
  • Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802
  • State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801
  • Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901
  • Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić", Služba za ispitivanje i lečenje bolesti srca i krvnih sudova - Site 3902
  • Department of Paediatric Cardiology University of the Free State - Site 6001
  • Paediatric Cardiology Albert Luthuli Central Hospital - Site 6003
  • Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002
  • Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907
  • Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906
  • Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103
  • Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101
  • Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bosentan 2 mg/Kg t.i.d.

Bosentan 2 mg/Kg b.i.d.

Arm Description

2 mg/kg bosentan administered three times a day (morning, afternoon, evening) for a planned duration of 24 weeks

2 mg/kg bosentan administered twice daily (morning and evening) for a planned duration of 24 weeks

Outcomes

Primary Outcome Measures

Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan
Daily exposure was measured by the area under the plasma concentration-time curve over a period of 24 hours [AUC(0-24)]. Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. AUC(0-24) was calculated as a multiple of AUCtau, which is the AUC over a dosing interval (AUCtau x 2 for the b.i.d. dosing regimen and AUCtau x 3 for the t.i.d. regimen). As the smallest dose unit was 8 mg (1/4 tablet), it was not possible to achieve the exact target dose of 2 mg/kg. Therefore, AUC(0-24) was corrected to 2 mg/kg (target dose) [AUC(0-24c)].

Secondary Outcome Measures

Full Information

First Posted
October 12, 2010
Last Updated
November 7, 2017
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01223352
Brief Title
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
Acronym
FUTURE 3
Official Title
An Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 8, 2011 (Actual)
Primary Completion Date
April 3, 2013 (Actual)
Study Completion Date
August 19, 2013 (Actual)

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
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
pulmonary arterial hypertension, children, pediatric, bosentan

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bosentan 2 mg/Kg t.i.d.
Arm Type
Experimental
Arm Description
2 mg/kg bosentan administered three times a day (morning, afternoon, evening) for a planned duration of 24 weeks
Arm Title
Bosentan 2 mg/Kg b.i.d.
Arm Type
Experimental
Arm Description
2 mg/kg bosentan administered twice daily (morning and evening) for a planned duration of 24 weeks
Intervention Type
Drug
Intervention Name(s)
bosentan
Other Intervention Name(s)
Tracleer, ACT-050088
Intervention Description
32 mg quadrisected dispersible tablet. The dosage of bosentan (2 mg/Kg) was adjusted according to the patient's body weight at initiation of the study treatment. Dosage readjustment was permitted after 12 weeks of treatment.
Primary Outcome Measure Information:
Title
Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan
Description
Daily exposure was measured by the area under the plasma concentration-time curve over a period of 24 hours [AUC(0-24)]. Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. AUC(0-24) was calculated as a multiple of AUCtau, which is the AUC over a dosing interval (AUCtau x 2 for the b.i.d. dosing regimen and AUCtau x 3 for the t.i.d. regimen). As the smallest dose unit was 8 mg (1/4 tablet), it was not possible to achieve the exact target dose of 2 mg/kg. Therefore, AUC(0-24) was corrected to 2 mg/kg (target dose) [AUC(0-24c)].
Time Frame
0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment
Other Pre-specified Outcome Measures:
Title
Dose-corrected Maximum Plasma Concentration [Cmaxc] of Bosentan
Description
Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. The peak plasma concentration (Cmax) of bosentan was directly obtained from the measured plasma concentrations and was dose-corrected to the target dose of 2 mg/kg (Cmaxc).
Time Frame
0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment
Title
Time to Reach Cmax [Tmax] of Bosentan
Description
Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. tmax was obtained directly from the measured plasma concentrations.
Time Frame
0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment
Title
Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056)
Description
Concentrations of the metabolites were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. Daily exposure to the metabolites corresponds to the area under the concentration-time curve [AUC(0-24)] of the corresponding metabolite over a period of 24 hours, and was calculated in the same manner as the primary endpoint. AUC(0-24c) was corrected to 2 mg/kg (target dose) [AUC(0-24c)].
Time Frame
0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment
Title
Change From Baseline in WHO Functional Class at End of Study
Description
The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension (PH): Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class IIII (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms. Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined.
Time Frame
Baseline, up to Week 24 on average
Title
Change From Baseline in Global Clincial Impression Scale (GCIS) at End of Study
Description
The GCIS is an assessment tool providing a single global assessment of the patient's current overall clinical condition: Very Good, Good, Neither Good or Bad, Bad and Very Bad. The assessment was performed both by the physician and the parents / legal representatives independently. Global clinical impression (GCI) at end of study was compared to GCI at baseline and the number of patients with clinical condition considered as worsened, improved or unchanged are determined.
Time Frame
Baseline, up to Week 24 on average
Title
Number of Patients With Treatment-emergent Liver Function Abnormalities
Description
Number of patients with increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN). The worst post-baseline value was considered. The treatment-emergent period was defined as study treatment start date up to 7 calendar days after study treatment end date.
Time Frame
Baseline, up to Week 24
Title
Number of Patients With Treatment-emergent Hemoglobin Abnormalities
Description
Number of patients with marked hemoglobin decreases (absolute values below 10 g/dL). The worst post-baseline value was considered. The treatment-emergent period was defined as study treatment start date up to 7 calendar days after study treatment end date.
Time Frame
Baseline, up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PAH diagnosis confirmed with right heart catheterization (RHC): Idiopathic or heritable PAH, or Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery) or PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary shunts (after global amendment dated 09 May 2012) World Health Organization functional Class (WHO FC) I, II or III Male or female ≥ 3 months and < 12 years of age (maximum age at randomization is 11.5 years) Body weight ≥ 3.5 kg Peripheral oxygen saturation (SpO2) ≥ 88% (at rest, on room air) Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase type-5 inhibitor) if present, has to be stable for at least 3 months prior to screening. During the study, all background treatments should remain stable Signed informed consent by the parents or legal representatives Exclusion Criteria: PAH etiologies other than listed above Non-stable disease status Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost Systolic blood pressure < 80% of the lower limit of normal range Aspartate aminotransferase and/or alanine aminotransferase values > 1.5 times the upper limit of normal range. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest: Glibenclamide (glyburide) Cyclosporin A Sirolimus Tacrolimus Fluconazole Rifampicin (rifampin) Ritonavir Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole) Endothelin receptor antagonists (ERAs) other than bosentan Treatment with another investigational drug within 1 month prior to randomization or planned treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andjela Kusic-Pajic, MD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
The Children's Hospital - Site 9102
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center - Site 9104
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Texas Children's Hospital - Department of Cardiology - Site 9107
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Children's Hospital - Site 9106
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Royal Children's Hospital Melbourne, Cardiology - Site 5001
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
The Republican Scientific-Practical Center "Cardiology" - Site 3001
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
Facility Name
Beijing Anzhen Hospital, Capital Medical University- Department of Pediatric Cardiology - Site 5103
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Cardiovascular Institute and Fuwai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
West China 2nd university Hospital-Center of interventional diagnosis and therapy for Children's cardiovascular disease - Site 5104
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Guangdong General Hospital - Site 5105
City
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Shanghai Children's Medical Center - Site 5102
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Shanghai Pulmonary Hospital, Department of Pulmonary Circulation - Site 5101
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Deutsches Herzzentrum Kinderkardiologie - Site 1401
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404
City
Bonn
ZIP/Postal Code
53113
Country
Germany
Facility Name
Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302
City
Hyderabad
ZIP/Postal Code
500001
Country
India
Facility Name
Indraprashta Apollo Hospitals, Pediatric Cardiology - Site 5303
City
New Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101
City
Petach Tikvah
ZIP/Postal Code
49202
Country
Israel
Facility Name
Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502
City
Rome
ZIP/Postal Code
00193
Country
Italy
Facility Name
Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Unidad de Investigacion Clinica en Medicina, SC (UDICEM) - Site 8402
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Universitair Medish Centrum Groningen, Kindercardiologie - Site 1601
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki Klinika Kardiologii ICMP w Lodz - Site 3602
City
Lodz
ZIP/Postal Code
93-336
Country
Poland
Facility Name
Instytut Pomnik - Centrum Zdrowia Dziecka Klinika Kardiologii Dziecięcej - Site 3601
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804
City
Moscow
ZIP/Postal Code
125412
Country
Russian Federation
Facility Name
Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802
City
St. Petersberg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić", Služba za ispitivanje i lečenje bolesti srca i krvnih sudova - Site 3902
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Department of Paediatric Cardiology University of the Free State - Site 6001
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Paediatric Cardiology Albert Luthuli Central Hospital - Site 6003
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103
City
Dnepropetrovsk
ZIP/Postal Code
49060
Country
Ukraine
Facility Name
Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102
City
Kiev
ZIP/Postal Code
01135
Country
Ukraine

12. IPD Sharing Statement

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Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension

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