Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)

PHASE3CompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions
Pulmonary Hypertension
Interventions
DRUG

Inhaled treprostinil

Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.

DRUG

Placebo inhalation solution

Doses are titrated to 9 breaths four times daily.

Trial Locations (30)

1070

Universite Libre de Bruxelles, Brussels

1090

Universitatsklinikfur Innere Medizin II, Wein

10003

Bethe Israel Medical Center, New York

15212

Allegheny General Hospital, Pittsburgh

21205

Johns Hopkins University, Baltimore

27710

Duke University Medical Center, Durham

31096

Rambam Medical Center, Haifa

32806

Orlando Heart Center, Orlando

66160

Kansas University Medical Center, Kansas City

75235

UTSW Medical Center, Dallas

80045

University of Colorado, Aurora

85724

University of Arizona, Tucson

90502

UCLA Medical Center, Torrance

92037

UCSD Medical center, La Jolla

92141

Hospital Antoine Beclere, Paris

35294-0006

University of Alabama, Birmingham

02111

Tufts Medical Center, Boston

48109-5853

University of Michigan, Ann Arbor

37232-2650

Vanderbilt University Medical Center, Nashville

Unknown

Medical University Graz, Graz

University Hospital Gasthuisburg, Leuven

Pulmonary Hypertension Unit, Dublin

The Pulmonary Institute, Jerusalem

The Pulmonary Institute, Petach Tikvah 49100

Instituto Malattie dell'Apparato Vascolare, Bologna

Scottish Pulmonary Vascular Unit, Glasgow GII 6NT

Royal Fee Hospital, London

D-35392

Univesitatsklinikum Giessen und Marburg GmbH, Geißen

08036

University of Barcelona, Barcelona

CB3 8RE

Papworth Hospital, Cambridge

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY