Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

May 21, 2013

Primary Completion Date

December 1, 2016

Study Completion Date

December 1, 2016

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Macitentan 10 mg

Macitentan 10 mg oral tablet once daily

DRUG

Placebo

Macitentan-matching placebo oral tablet once daily

Trial Locations (55)

1309

Mhat Nat Card Hosp - Cardiology Clinic, Sofia

Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept, Sofia

1750

Mhat Sveta Anna Clin Card, Sofia

11040

Dedinje Cardiovasc Inst - Cardiovasc Research Ctr, Belgrade

11070

"Mother and Child Health Care Inst Dr Vukan Cupic", Belgrade

11080

Clin Hosp Ctr Zemun - Cardiology Dept, Belgrade

13353

Herzzentrum Berlin, Ped Cardiology, Berlin

13385

Hosp La Timone - Dept Pediatric Cardiology, Marseille

14080

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

30322

Emory University Hospital/the Emory Clinic, Atlanta

33604

Hosp Cardiology Haut Leveque - Dept Congenital Diseases, Pessac

35392

Universitätsklinikum Giessen - Pediatric Heart Center, Giessen

41007

Hosp Univ Virgen Macarena - Dpt Cardiology, Seville

43210

Nationwide Children's Hospital, Columbus

44093

Hosp Laennec - Dept Cardiology, Nantes

46009

Hosp Universitario La Fe Dpt Cardiology, Valencia

49100

Rabin Medical Centre - Pulmonology, Petach Tikvah

50400

Institut Jantung Negara, Kuala Lumpur

54636

Ahepa University General Hospital, Thessaloniki

55139

Omu Pediatry, Samsun

63110

Barnes-Jewish Hosp/Wash Univ School of Med, St Louis

64718

Unidad de Investigacion Clin En Med, Sc (Udicem), Monterrey

75908

Hosp Pompidou - Dept Congenital Cardiac Diseases, Paris

89109

Children'S Heart Center Nevada, Las Vegas

90095

Ahmanson/UCLA Heart Disease Center, Los Angeles

94304

Stanford Hospital and Clinic, Palo Alto

100029

Beijing Anzhen Hospital, Cardiology Dpt, Beijing

100037

Cardiovascular Institute&Fuwai Hospital, Beijing

110016

The General Hosp of Shenyang Military Region, Shenyang

121552

Russian Cardiology Scientific and Production Complex, Moscow

197341

V. A. Almazov Institute of Cardiology, Saint Petersburg

200433

Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation, Shanghai

300312

Clin Hosp For Inf and Pulm Dis Victor Babes - Ii Pulm, Timișoara

430022

Wu Han Asia Heart Hosp, Wuhan

510080

Guangdong General Hospital, Cardiology Dpt, Guangzhou

540136

Cardio Med Srl, Târgu Mureş

650002

Sci Institute Systemic Problems Cardio Diseases Kemerovo, Kemerovo

7650018

Clinica Tabancura - Cardio Unit, Santiago

77030-2303

Texas Children'S Hosp - Dept of Cardiology, Houston

A-1090

Gen Hosp Univ Vienna Dept Cardiology, Vienna

Unknown

Inst Nat Torax, Unidad Cardiopatia Congenitas Del Adulto, Providencia

Instituto de Corazon de Querètaro, Querétaro

PHC, MAB, Manila

Hanoi Medical University Hospital, Hanoi

Children's Hospital, Ho Chi Minh, Ho Chi Minh City

Tam Duc Hospital, Ho Chi Minh City

D-69120

Uni Heidelberg - Kinderkardiologie, Heidelberg

80-952

Cardiology Gdańsk Univ, Gdansk

31-202

Cardiology Kraków Univ, Krakow

51-124

Cardiology Wrocław, Wroclaw

3000-075

Hosp Univ Coimbra - Dpt Cardiology, Coimbra

1169-024

Hosp Sta Marta - Dept Cardiology, Lisbon

022328

"Er Inst For Cardvasc Dis Prof Dr Cc Iliescu - Card Ii", Bucharest

08035

Hosp Univ Vall D'Hebron - Dpt Congenital Heart Disease Adult, Barcelona

BS2 8BJ

Bristol Univ Hosp Congenital Heart Centre, Bristol

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY