Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation

PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

March 28, 2016

Primary Completion Date

March 13, 2020

Study Completion Date

March 13, 2020

Conditions
Pulmonary Hypertension
Interventions
DRUG

Macitentan 10mg

2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo

DRUG

Placebo sugar pill

2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo

Trial Locations (50)

10021

#103_Weill Cornell Medical College, New York

10467

#133_Montefiore Medical Center, The Bronx

10595

#147_Westchester Medical Center, Valhalla

15212

#134_Allegheny General Hospital, Pittsburgh

15213

#130_University of Pittsburgh Medical Center, Pittsburgh

17033

#142_Penn State Heart and Vascular Institute, Hershey

19104

#140_Hospital of the University of Pennsylvania, Philadelphia

20010

#123_MedStar Washington Hospital Center, Washington D.C.

21287

#129_John Hopkins University Medical Center, Baltimore

22042

#111_Inova Fairfax Hospital, Falls Church

22905

#114_University of Virginia, Charlottesville

23298

#116_Virginia Commonwealth University (VCU) Medical Center, Richmond

29203

#141_Palmetto Health / Palmetto Heart, Columbia

29425

Medical University of South Carolina, Charleston

32804

#126_Florida Hospital, Orlando

37232

#146_Vanderbilt University Medical Center, Nashville

38120

#151_Stern Cardiovascular Foundation, Memphis

40202

#117_University of Louisville, Louisville

43210

#101_The Ohio State University Wexner Medical Center, Columbus

43614

#145_The University of Toledo Medical Center, Toledo

44195

#153_Cleveland Clinic, Cleveland

45242

#148_University of Cincinnati Medical Center, Cincinnati

46202

#108_Indiana University Health Physicians Cardiology, Indianapolis

46260

#112_St. Vincent Medical Group, Inc, Indianapolis

48202

#115_Henry Ford Hospital, Detroit

52242

#120_University of Iowa Hospitals and Clinics, Iowa City

53792

#155_University of Wisconsin Hospital and Clinics, Madison

55905

#102_Mayo Clinic, Rochester

60453

#113_Advocate Christ Medical Center, Oak Lawn

60637

#135_University of Chicago Medical Center, Chicago

63110

#104_Washington University School of Medicine, St Louis

64111

#150_Saint Luke's Hospital, Kansas City

68918

#131_University of Nebraska Medical Center, Omaha

70121

#105_Ochsner Medical Center, New Orleans

73112

#121_Integris Baptist Medical Center, Oklahoma City

75226

#136_Baylor Health - Baylor University Medical Center, Dallas

77030

#107_Houston Methodist Hospital, Houston

78229

#122_Advanced Heart Failure Clinic - HCM, San Antonio

78705

#149_Seton Heart Institute, Austin

84112

#127_The University of Utah, Salt Lake City

85054

#125_Mayo Clinic Arizona, Phoenix

85724

#144_University of Arizona, Tucson

90211

#106_Cedars-Sinai Medical Center, Beverly Hills

92037

#154_University of California San Diego, La Jolla

94080

#139_Icahn School of Medicine at Mount Sinai, New York

94143

#132_University of California San Francisco, San Francisco

95819

#110_Sutter Heart Institute, Sacramento

02111

#143_Tufts Medical Center, Boston

02114

#138_Massachusetts General Hospital, Boston

02115

#119_Brigham and Women's Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY