The purpose of this study is to determine the safety and efficacy of Iloprost is safe and effective in subjects that have 'Pulmonary Arterial Hypertension' and are concurrently taking bosentan (Tracleer TM).

Condition	Treatment or Intervention	Phase
Pulmonary Arterial Hypertension PAH Pulmonary Hypertension	Drug: Iloprost or placebo	Phase II

This randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label iloprost will be provided.

Ages Eligible for Study:  12 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (≥ 1 year) ASD, VSD, or PDA
• NYHA Functional Class III or IV
• On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for at least 8 weeks
• Age 12-75 years, of either gender
• Six minute walk distance 100-425 meters at Baseline

Exclusion Criteria:

• Any new long-term treatment for PAH added within the last 4 weeks
• Any therapy with a PDE (phosphodiesterase),L -arginine or a prostaglandin, concurrently, or within the last 4 weeks
• PAH related to chronic thromboembolic disease, portopulmonary disease, or any etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or PDA

Jennifer Kano      650 808 6500    jkano@cotherix.com

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Not yet recruiting
California
      UCSD Medical Center, La Jolla,  California,  92037,  United States; Not yet recruiting
      UCSF Medical Center, San Francisco,  California,  94143,  United States; Recruiting
      Stanford University Medical Center, Palo Alto,  California,  94305,  United States; Not yet recruiting
      Harbor-UCLA Medical Center, Torrance,  California,  90502,  United States; Not yet recruiting
Colorado
      University of Colorado HSC, Denver,  Colorado,  80262,  United States; Recruiting
      The Children's Hospital, Denver,  Colorado,  80218,  United States; Not yet recruiting
Illinois
      Rush Heart Institute, Center for Pulmonary Heart Disease, Chicago,  Illinois,  60612,  United States; Recruiting
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21205,  United States; Recruiting
Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109,  United States; Not yet recruiting
Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55095,  United States; Not yet recruiting
New York
      Columbia University Medical Center, New York,  New York,  10032,  United States; Not yet recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Not yet recruiting
Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232,  United States; Not yet recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Not yet recruiting
Utah
      Latter Day Saints Hospital, Salt Lake City,  Utah,  84143,  United States; Not yet recruiting

Study chairs or principal investigators

Keith Nolop, M.D.,  Study Director,  CoTherix   

Study ID Numbers:  STEP STUDY; STEP; Pulmonary Hypertension; Pulmonary Artery; Cotherix
Record last reviewed:  July 2004
Record first received:  July 1, 2004
ClinicalTrials.gov Identifier:  NCT00086463
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10