FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)

PHASE3CompletedINTERVENTIONAL
Enrollment

354

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

September 30, 2008

Study Completion Date

December 31, 2010

Conditions
Pulmonary Hypertension
Interventions
DRUG

Oral treprostinil (UT-15C) sustained release tablets

UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours

DRUG

Placebo

Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours

Trial Locations (72)

10032

Columbia Presbyterian Medical Center, New York

14643

Mary M Parkes Center for Asthma, Allergy and Pulmonary Care, Rochester

15212

Allegheny General Hospital, Pittsburgh

15213

University of Pittsburgh Medical Center, Pittsburgh

21201

University of Maryland School of Medicine, Baltimore

21205

John's Hopkins Hospital, Baltimore

22042

Inova Transplant Center, Fairfax

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

35294

University of Alabama-Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

43210

Ohio State University, Columbus

44106

University Hospitals of Cleveland, Cleveland

44195

The Cleveland Clinic Foundation, Cleveland

48109

University of Michigan, Ann Arbor

52242

University of Iowa Health Care, Iowa City

53215

Heart Care Associates, Milwaukee

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic, Rochester

60637

University of Chicago, Chicago

63110

Washington University Hospital, St Louis

75235

UT Southwestern, Dallas

77030

Baylor College of Medicine, Pulmonary & Critical Care, Houston

78229

The University of Texas Health Science Center at San Antonio, San Antonio

80218

The Children's Hospital, Aurora

80262

Pulmonary Hypertension Clinic, Aurora

84143

Intermountain Medical Center, Murray

85013

Arizona Pulmonary Specialist, Phoenix

85724

University of Arizona Health Science Center, Tucson

90073

West Los Angeles VA Healthcare Center, Los Angeles

90502

Harbour-UCLA Medical Center, Torrance

94143

University of California-San Francisco, San Francisco

94305

Stanford University, Pulmonary and Critical Care, Palo Alto

95817

UC Davis Medical Center, Sacramento

97239

Legacy Clinic Northwest, Portland

98195

University of Washington Medical Center, Seattle

04102

Maine Medical Center, Portland

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

Unknown

St. Vincent's Hospital, Sydney

The Prince Charles Hospital, Brisbane

The Alfred Hospital, Melbourne

Royal Perth Hospital, Perth

Medizinische Universität Innsbruck, Innsbruck

Universitaet Wien, Vienna

Hospital Erasme, Brussels

University Hospital Gasthuisberg, Leuven

Respiratory Research, Calgary

Hospital Cavale Blanche, Brest

Hospital Antoine Beclere, Clamart

Hospital Claude Huriez, Lille

Hôpital Louis Pradel, Lyon

Medizinische Hochschule Hannover, Hanover

Mater Misericordiae University Hospital Ltd, Dublin

Hadassah Ein-Kerem Medical Center, Jerusalem

Rabin Medical Center, Petah Tikva

Tel Hashomer Medical Center, Ramat Gan

Universita degli Studi Bologna, Bologna

"Universita La Sapienza Roma", Rome

Hospital Vrije Universiteit, Amsterdam

National Tuberculosis and Lung Disease Research Institute, Warsaw

Hospital Clinic of Barcelona, Barcelona

Hospital Valle Hebron, Barcelona

Hospital 12 de Octubre, Madrid

Papworth Hospital, Cambridge

Western Infirmary, Glasgow

Royal Free Hospital, London

Freeman Hospital, Newcastle

V5Z 3J5

Vancouver Coastal Health Respiratory Clinic, Vancouver

N6A 4G5

Lab London Health Sciences Center, London

M5G 2N2

Toronto General Hospital, Toronto

H3T 1E2

SMBD Jewish General Hospital, Montreal

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY