Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 20, 2014

Primary Completion Date

September 28, 2016

Study Completion Date

September 28, 2016

Conditions
Chronic Thromboembolic Pulmonary Hypertension
Interventions
DRUG

Macitentan

Macitentan 10 mg, oral tablet, to be taken once daily.

DRUG

Placebo

Matching placebo oral tablet, to be taken once daily.

Trial Locations (36)

1125

Semmelweis Egyetem, Budapest

3000

University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie, Leuven

3722

Severance Hospital, YonSei University Health System, Seoul

4032

Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Kardiológiai Klinika, Debrecen

8091

University Hospital Zürich, Zurich

10330

King Chulalongkorn Memorial Hospital, Division of Respiratory and Respiratory Critical Care Medicine, Bangkok

10700

Siriraj Hospital, Division of Respiratory Disease and Tuberculosis, Bangkok

14080

Instituto Nacional de Cardiologia (INC) Ignacio Chavez, Mexico City

31059

CHU de Toulouse Hopital Larrey, Toulouse

34093

Istanbul University İstanbul Faculty Medicine Pulmonology Department, Capa_Istanbul

35392

Justus-Liebig-Universität Gießen, Giessen

50161

Lietuvos Sveikatos Mokslų Universiteto Ligoninės Kauno Klinikos Pulmonologijos-Imunologijos Klinika, Kaunas

50200

MAHARAJ NAKORN CHIANG MAI HOSPITAL, Department of Internal Medicine, Chiang Mai

69126

Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg

75908

Hôpital Européen Georges Pompidou Service de Pneumologie, soins intensifs et endoscopies bronchiques, Paris

79014

Lviv Regional Clinical Hospital, Cardiosurgery Department, Lviv

94275

CHU de Bicêtre, Le Kremlin-Bicêtre

97074

Missionsärztliche Klinik gGmbH Akademisches Lehrkrankenhaus der Julius-Maximilians-Universität, Würzburg

100020

Beijing Chao-Yang Hospital-Department of Respiration, Beijing

100037

Cardiovascular institute & Fuwai Hospital- Thrombus Center, Beijing

110016

The General Hospital of Shenyang Military Region,Congenital Heart Disease Department, Shenyang

121552

"Federal State Budgetary Institution Russian Cardiology Scientific and Production Complex of the Ministry of Health Care of the Russian Federation", Moscow

197341

"Federal State Institution Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies", Saint Petersburg

200433

ngShanghai Pulmonary Hospital, Department of Pulmonary Circulation, Shanghai

430022

Wuhan Asia Heart Hospital, Wuhan

510120

The first affiliated hospital of guangzhou medical university-respiratory department, Guangzhou

630055

E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rosmedtechnology, Novosibirsk

634012

"Federal State Budgetary Institution Research Institute for Cardiology of Siberian Branch under the Russian Academy of Medical Sciences / Cardiovascular Surgery Department", Tomsk

650002

"Federal State Budgetary Institution Scientific Research Institute of Systemic Problems of Cardiovascular Diseases, Siberian branch of RAMS", Kemerovo

128 08

Centre for PPH, Charles University , II Interni klinika1.LF a VFN, Prague

20-718

Wojewódzki Szpital Specjalistyczny w Lublinie im. Stefana Kardynała Wyszyńskiego SPZOZ Oddział Kardiologii - Pododdział Intensywnego Nadzoru Kardiologicznego, Lublin

51-124

Wojewódzki Szpital Specjalistyczny we Wrocawiu, Wrocaw

03680

State Institute of Phthisiology and Pulmonology n.a. F.G. Yanovskiy of AMS Ukraine, Kyiv

CB23 3RE

Papworth Hospital NHS Trust, Pulmonary Vascular Diseases Unit, Cambridge

W12 0HS

Hammersmith Hospital, London

S10 2RX

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Pulmonary Vascular Medicine, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
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Actelion

INDUSTRY