Back to resultsClinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension (SERAPHIN OL)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macitentan
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring SERAPHIN, Pulmonary Arterial Hypertension, ACT-064992
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent prior to initiation of any study-mandated procedure.
- Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
- Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
Exclusion Criteria:
- Any major violation of protocol AC 055 302/SERAPHIN.
- Pregnancy or breast-feeding.
- AST and/or ALT > 3 times the upper limit of the normal range.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
- Known hypersensitivity to ACT 064992 or any of the excipients.
Sites / Locations
- University of Alabama at Birmingham
- Arizona Pulmonary Specialists
- University of California, San Diego
- GLVA Healthcare Center
- Santa Barbara Cottage Hospital
- Liu Center for Pulmonary Hypertension
- University of Colorado CARDIAC AND VASCULAR CENTER
- University of Florida - Division of Pulmonology
- Mayo Clinic, Jacksonville
- Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease
- Pulmonary & Critical Care of Atlanta
- Atlanta Institute for Medical Research
- University of Chicago
- University of Iowa, Pulmonary Hypertension Program
- University of Kansas Medical Center
- Kentuckiana Pulmonary Associate, PLLC
- Louisiana State University Health Sciences Center
- Maine Medical Center
- University of Maryland School of Medicine; Division of Cardiology
- Pulmonary/Critical Care Division/Tufts New England Medical Center
- Massachusetts General Hospital
- Boston University School of Medicine
- University of Michigan
- Harper Univ. Hospital/ Wayne State University
- Washington University School of Medicine
- University of Nebraska Medical Center
- University of NJ - Robert Wood Johnson Medical School
- Columbia University Medical Center - Pediatric Cardiology
- Duke University Medical Center
- University of Cincinnati Ohio Heart Health Center
- Ohio State University, Div. of Pul. & Critical Care
- Allegheny General Hospital
- Vanderbilt University Medical Center
- University of Texas Medical Center - St. Paul University
- Baylor College of Medicine and the Methodist Hospital,
- University of Texas Houston Health Center
- Intermountain Med Ctr- Pulm Dept Heart and Lung Ctr
- Sentara Hospitals T/A Sentara Cardiovascular Research Intitute
- Aurora St. Luke's Medical Center
- Sanatorio Otamendi y Miroli S.A.
- Hospital Britanico
- Sanatorio MITRE
- Fundacion Favaloro
- Htal Italiano Cordoba
- Htla privado de Cordoba
- Instituto Cardiologia Corrientes
- Hospital Italiano - Garibaldi de Rosario
- St. Vincent's Hospital
- The Alfred Hospital
- Royal Brisbane Hospital
- Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology
- Republican reserach - Pratical Centre of Cardiology
- Minsk Regional Clinical Hospital
- Vitebsk Regional Clinical Hospital
- University Hospital Gasthuisberg
- Mhat Nat Card Hosp - Pediatric Clinic
- Peter Lougheed Centre
- London Health Sciences Centre
- Toronto General Hospital
- L'Hopital Laval
- Hospital del Torax
- Pontificia Universidad Catolica de Chile
- Hospital San Juan de Dios
- Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department
- Peking Union Medical College Hospital, Rheumatology Department
- Guangdong General Hospital, Cardiology Department
- Jiangsu Province Hospital - Pneumology Department
- Renji Hospital, Rheumatology Department
- Zhongshan Hospital Fudan University, Cardiology Department
- Renji Hospital, Cardiology Department
- Shanghai Pulmonary Hospital Department of Pulmonary Circulation
- Fundacion Cardiovascular de Colombia
- Fundacion Clinica Shaio
- Clinical Hospital Center
- Helsinki University Central Hospital
- Hosp Bicetre - Dept Pulmo & Resp Intensive Care
- Hopital Arnaud de Villeneuve Service des Maladies Respiratoires
- Hopital Haut-Leveque-Maison du Haut-Leveque
- Unfallkrankenhaus Berlin, Klinik für Innere Medizin
- Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus
- Universitätsklinikum Essen, Klinik für Kardiologie , Zentrum für Innere Medizin
- Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med. / Pneumologie
- Universität Greifswald / Klinik für Innere Medizin B,
- Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie
- Medizinische Hochschule Hannover / Klinik für Pneumologie
- Thoraxklinik am Universitätsklinikum Heidelberg
- Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V
- Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie
- Universtätsklinik Leipzig
- Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie
- Universitatsklinikum Regensburg/Innere Medizin II
- Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics
- Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)
- "Semmelweis Egyetem, Pulmonológiai Klinika"
- University of Pecs, Medical School/Heart Institute and 1st Department of Internal Medicine
- University of Szeged Albert Szent-Gyorgyi Medical & Pharmaceutical Center
- Life Care Institute of Medical Science & Research, Ahmedabad
- Care Hospital
- Seth GS Medical College & King Edward VII Memorial (KEM) Hospital / Department Of Cardiology
- P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine
- G B Pant Hospital & Maulana Azad Medical College
- Deenanath Mangeshkar Hospital and Research Centre
- Rambam Health Care Campus / Division of Medicine, Institute of Pulmonology
- Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division
- Rabin Medical Center - Belinson campus - Pulmonary Institute
- Pulmonary Institute, Kaplan Medical Center
- The pulmonary institute Sheba Medical centre
- Sourasky Medical Center - Division of Pulmonary Medicine and Allergy
- IRCCS Policlinico San Matteo Policlinico / Dipartimento di Cardiologia
- Policlinico Umberto I, Cardiologia
- Institut Jantung Negara (National Heart Institute)
- Instituto Nacional de Cardiología (INC) Ignacio Chávez
- Unidad de Investigación Clinica en Medicina
- VU Medisch Centrum, Dept. Pulmonology 4A 48
- St. Antonius ziekenhuis
- Hospital Alberto Sabogal Sologuren - EsSALUD
- Clinica Medica Cayetano Heredia
- Instituto de Enfermedades Respiratorias
- Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ
- Cardiology Otwock Priv
- III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego
- Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie
- Institutul de boli cardiovasculare / Clinica de Cardiologie
- Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)
- Municipal Health Care Institution Kemerovo Cardiology Dispensary
- Federal State Institution "State Scientific Research Centre of Preventive Medicine" of Rosmedtechnology
- Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"
- State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"
- Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"
- State Educational Institution "St Petersburg Medical Academy of Postgraduate Education" of Federal Agency of Public Health and Social Development
- State Educational Institution of High Professional Education "St Petersburg State Medical
- Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology
- State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch
- Tomsk Regional Clinical Hospital / Pulmonology Unit
- Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"
- University Children's Hospital (UNIVERZITETSKA DECJA KLINKIKA)
- University Clinical Center of Serbia/ Institute for Lung Diseases and Tuberculosis
- Zemun Clinical Hospital (Klinicko-bolnicki centar Zemun) / Department of Cardiology
- National University Hospital/ The Heart Institute
- National Heart Centre (Nhc) Singapore
- National Institute of Cardiovascular Diseases (Slovenska zdravotnicka univerzita) / Faculty of Medical Specialty Studies (Fakulta zdravotnickych speci
- Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií)
- Tread Research
- Chris Hani Baragwanath Hospital, Department of Cardiology
- Netcare Milpark Hospital,Center for Chest Disease
- Block 4, Vergelegen Medi-Clinic
- University Hospital of Lund, Dept. of Cardiology
- Uppsala University Hospital, Cardiology
- Taichung Veterans General Hospital
- National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department
- Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,
- Siriraj Hospital, Mahidol University
- Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology
- Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University
- Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid
- Danylo Galytskyi Lviv State Medical University
- Odessa State Medical University, Military-medical Clinical Center of the South region
- Royal Free Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACT-064992
Arm Description
ACT-064992
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Number of Participants With Death up to 28 Days After Study Treatment Discontinuation
Number of participants with deaths up to 28 days after study treatment discontinuation were reported.
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above.
Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment
Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation
Number of participants with treatment-emergent abnormal liver tests: Alanine aminotransferase (ALT) greater than (>) 3*upper limit of normal (ULN) or aspartate aminotransferase (AST) >3* ULN, ALT >5* ULN or AST >5*ULN, ALT >8*ULN or AST >8*ULN, total bilirubin (TBIL) >2*ULN, ALT >3*ULN or AST >3*ULN and TBIL >2*ULN at any time were reported.
Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation
Number of participants with treatment-emergent hemoglobin (HGB) abnormality up to 28 days after study treatment discontinuation were reported. Participants assessed for different categories of HGB were <=80 grams/Liter (g/L), <=100g/L, decrease from baseline >=20 g/L, and decrease from baseline >=50 g/L.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00667823
Brief Title
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Acronym
SERAPHIN OL
Official Title
Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2008 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
SERAPHIN, Pulmonary Arterial Hypertension, ACT-064992
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACT-064992
Arm Type
Experimental
Arm Description
ACT-064992
Intervention Type
Drug
Intervention Name(s)
Macitentan
Other Intervention Name(s)
ACT-064992
Intervention Description
Tablet, oral administration, 10 mg dose once daily
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation
Description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Time Frame
Up to 28 days after study treatment discontinuation (Up to 12 years)
Title
Number of Participants With Death up to 28 Days After Study Treatment Discontinuation
Description
Number of participants with deaths up to 28 days after study treatment discontinuation were reported.
Time Frame
Up to 28 days after study treatment discontinuation (Up to 12 years)
Title
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation
Description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above.
Time Frame
Up to 28 days after study treatment discontinuation (Up to 12 years)
Title
Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment
Description
Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame
Up to 28 days after study treatment discontinuation (Up to12 years)
Title
Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation
Description
Number of participants with treatment-emergent abnormal liver tests: Alanine aminotransferase (ALT) greater than (>) 3*upper limit of normal (ULN) or aspartate aminotransferase (AST) >3* ULN, ALT >5* ULN or AST >5*ULN, ALT >8*ULN or AST >8*ULN, total bilirubin (TBIL) >2*ULN, ALT >3*ULN or AST >3*ULN and TBIL >2*ULN at any time were reported.
Time Frame
Up to 28 days after study treatment discontinuation (Up to12 years)
Title
Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation
Description
Number of participants with treatment-emergent hemoglobin (HGB) abnormality up to 28 days after study treatment discontinuation were reported. Participants assessed for different categories of HGB were <=80 grams/Liter (g/L), <=100g/L, decrease from baseline >=20 g/L, and decrease from baseline >=50 g/L.
Time Frame
Up to 28 days after treatment discontinuation (Up to 12 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent prior to initiation of any study-mandated procedure.
Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
Exclusion Criteria:
Any major violation of protocol AC 055 302/SERAPHIN.
Pregnancy or breast-feeding.
AST and/or ALT > 3 times the upper limit of the normal range.
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
Known hypersensitivity to ACT 064992 or any of the excipients.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-0001
Country
United States
Facility Name
Arizona Pulmonary Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
GLVA Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Liu Center for Pulmonary Hypertension
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2006
Country
United States
Facility Name
University of Colorado CARDIAC AND VASCULAR CENTER
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2548
Country
United States
Facility Name
University of Florida - Division of Pulmonology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32259
Country
United States
Facility Name
Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Pulmonary & Critical Care of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1713
Country
United States
Facility Name
Atlanta Institute for Medical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1432
Country
United States
Facility Name
University of Iowa, Pulmonary Hypertension Program
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1081
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kentuckiana Pulmonary Associate, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-1393
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102-3134
Country
United States
Facility Name
University of Maryland School of Medicine; Division of Cardiology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Facility Name
Pulmonary/Critical Care Division/Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Harper Univ. Hospital/ Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
University of NJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903-0010
Country
United States
Facility Name
Columbia University Medical Center - Pediatric Cardiology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-0001
Country
United States
Facility Name
University of Cincinnati Ohio Heart Health Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219-2906
Country
United States
Facility Name
Ohio State University, Div. of Pul. & Critical Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Medical Center - St. Paul University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8550
Country
United States
Facility Name
Baylor College of Medicine and the Methodist Hospital,
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Houston Health Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Med Ctr- Pulm Dept Heart and Lung Ctr
City
Murray
State/Province
Utah
ZIP/Postal Code
84157-5701
Country
United States
Facility Name
Sentara Hospitals T/A Sentara Cardiovascular Research Intitute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1904
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53125
Country
United States
Facility Name
Sanatorio Otamendi y Miroli S.A.
City
Buenos Aires
State/Province
Ciudad Autonoma
ZIP/Postal Code
C1121ABL
Country
Argentina
Facility Name
Hospital Britanico
City
Buenos Aires
State/Province
Ciudad Autonoma
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Sanatorio MITRE
City
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Facility Name
Fundacion Favaloro
City
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Htal Italiano Cordoba
City
Cordoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Htla privado de Cordoba
City
Cordoba
ZIP/Postal Code
x5016keh
Country
Argentina
Facility Name
Instituto Cardiologia Corrientes
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Hospital Italiano - Garibaldi de Rosario
City
Santa Fe
ZIP/Postal Code
S2001ODA
Country
Argentina
Facility Name
St. Vincent's Hospital
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Sunshine Coast
ZIP/Postal Code
4558
Country
Australia
Facility Name
Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Republican reserach - Pratical Centre of Cardiology
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
Facility Name
Minsk Regional Clinical Hospital
City
Minsk
ZIP/Postal Code
223041
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Mhat Nat Card Hosp - Pediatric Clinic
City
Sofia
State/Province
BG
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2R5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
L'Hopital Laval
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Hospital del Torax
City
Santiago de Chile
ZIP/Postal Code
7500691
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile
City
Santiago de Chile
ZIP/Postal Code
833034
Country
Chile
Facility Name
Hospital San Juan de Dios
City
Santiago
ZIP/Postal Code
8350488
Country
Chile
Facility Name
Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking Union Medical College Hospital, Rheumatology Department
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Guangdong General Hospital, Cardiology Department
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Jiangsu Province Hospital - Pneumology Department
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Renji Hospital, Rheumatology Department
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Zhongshan Hospital Fudan University, Cardiology Department
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Renji Hospital, Cardiology Department
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Shanghai Pulmonary Hospital Department of Pulmonary Circulation
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Fundacion Cardiovascular de Colombia
City
Floridablanca
State/Province
Santander
Country
Colombia
Facility Name
Fundacion Clinica Shaio
City
Bogota
Country
Colombia
Facility Name
Clinical Hospital Center
City
Rijeka
ZIP/Postal Code
51 000
Country
Croatia
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Hosp Bicetre - Dept Pulmo & Resp Intensive Care
City
Le Kremlin-Bicêtre cedex
ZIP/Postal Code
94275
Country
France
Facility Name
Hopital Arnaud de Villeneuve Service des Maladies Respiratoires
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Haut-Leveque-Maison du Haut-Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Unfallkrankenhaus Berlin, Klinik für Innere Medizin
City
Berlin
ZIP/Postal Code
12683
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Essen, Klinik für Kardiologie , Zentrum für Innere Medizin
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med. / Pneumologie
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universität Greifswald / Klinik für Innere Medizin B,
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover / Klinik für Pneumologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thoraxklinik am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie
City
Koln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Universtätsklinik Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitatsklinikum Regensburg/Innere Medizin II
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics
City
Hong Kong
Country
Hong Kong
Facility Name
Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
"Semmelweis Egyetem, Pulmonológiai Klinika"
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
University of Pecs, Medical School/Heart Institute and 1st Department of Internal Medicine
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
University of Szeged Albert Szent-Gyorgyi Medical & Pharmaceutical Center
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Life Care Institute of Medical Science & Research, Ahmedabad
City
Ahmedabad
ZIP/Postal Code
382428
Country
India
Facility Name
Care Hospital
City
Hyderabad
ZIP/Postal Code
500001
Country
India
Facility Name
Seth GS Medical College & King Edward VII Memorial (KEM) Hospital / Department Of Cardiology
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine
City
Mumbai
ZIP/Postal Code
400016
Country
India
Facility Name
G B Pant Hospital & Maulana Azad Medical College
City
New Delhi
ZIP/Postal Code
110 002
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
ZIP/Postal Code
411 004
Country
India
Facility Name
Rambam Health Care Campus / Division of Medicine, Institute of Pulmonology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Rabin Medical Center - Belinson campus - Pulmonary Institute
City
Petach - Tikvah
ZIP/Postal Code
49100
Country
Israel
Facility Name
Pulmonary Institute, Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
The pulmonary institute Sheba Medical centre
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky Medical Center - Division of Pulmonary Medicine and Allergy
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
IRCCS Policlinico San Matteo Policlinico / Dipartimento di Cardiologia
City
Pavia
ZIP/Postal Code
207100
Country
Italy
Facility Name
Policlinico Umberto I, Cardiologia
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Institut Jantung Negara (National Heart Institute)
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Instituto Nacional de Cardiología (INC) Ignacio Chávez
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Unidad de Investigación Clinica en Medicina
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Facility Name
VU Medisch Centrum, Dept. Pulmonology 4A 48
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
St. Antonius ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Hospital Alberto Sabogal Sologuren - EsSALUD
City
Callao
ZIP/Postal Code
Callao 02
Country
Peru
Facility Name
Clinica Medica Cayetano Heredia
City
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Instituto de Enfermedades Respiratorias
City
Lima
ZIP/Postal Code
32
Country
Peru
Facility Name
Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Cardiology Otwock Priv
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie
City
Bucharest
ZIP/Postal Code
050159
Country
Romania
Facility Name
Institutul de boli cardiovasculare / Clinica de Cardiologie
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Municipal Health Care Institution Kemerovo Cardiology Dispensary
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Federal State Institution "State Scientific Research Centre of Preventive Medicine" of Rosmedtechnology
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
State Educational Institution "St Petersburg Medical Academy of Postgraduate Education" of Federal Agency of Public Health and Social Development
City
St Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "St Petersburg State Medical
City
St Petersburg
ZIP/Postal Code
197 022
Country
Russian Federation
Facility Name
Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
Tomsk Regional Clinical Hospital / Pulmonology Unit
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"
City
Yaroslavl
ZIP/Postal Code
150 003
Country
Russian Federation
Facility Name
University Children's Hospital (UNIVERZITETSKA DECJA KLINKIKA)
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia/ Institute for Lung Diseases and Tuberculosis
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Zemun Clinical Hospital (Klinicko-bolnicki centar Zemun) / Department of Cardiology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
National University Hospital/ The Heart Institute
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Heart Centre (Nhc) Singapore
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Facility Name
National Institute of Cardiovascular Diseases (Slovenska zdravotnicka univerzita) / Faculty of Medical Specialty Studies (Fakulta zdravotnickych speci
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Facility Name
Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií)
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Facility Name
Tread Research
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Chris Hani Baragwanath Hospital, Department of Cardiology
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Netcare Milpark Hospital,Center for Chest Disease
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Block 4, Vergelegen Medi-Clinic
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
University Hospital of Lund, Dept. of Cardiology
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Uppsala University Hospital, Cardiology
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid
City
Dnepropetrovsk
ZIP/Postal Code
49060
Country
Ukraine
Facility Name
Danylo Galytskyi Lviv State Medical University
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Odessa State Medical University, Military-medical Clinical Center of the South region
City
Odessa
ZIP/Postal Code
65044
Country
Ukraine
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35819570
Citation
Souza R, Delcroix M, Galie N, Jansa P, Mehta S, Pulido T, Rubin L, Sastry BKS, Simonneau G, Sitbon O, Torbicki A, Boyanova N, Chamitava L, Stein C, Channick RN. Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension. Adv Ther. 2022 Sep;39(9):4374-4390. doi: 10.1007/s12325-022-02199-x. Epub 2022 Jul 12.
Results Reference
derived
PubMed Identifier
29501590
Citation
Krause A, Zisowsky J, Dingemanse J. Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension. Pulm Pharmacol Ther. 2018 Apr;49:140-146. doi: 10.1016/j.pupt.2018.02.005. Epub 2018 Feb 28.
Results Reference
derived
Learn more about this trial
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
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