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Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)

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ClinicalTrials.gov Identifier: NCT00086463
Recruitment Status : Completed
First Posted : July 5, 2004
Last Update Posted : April 1, 2011
Sponsor:
Information provided by:
Actelion

Study Description
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Brief Summary:
The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Ayerza Syndrome Pulmonary Hypertension Drug: Iloprost or placebo Phase 2

Detailed Description:
This is a 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH
Study Start Date : June 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086463


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCSD Medical Center
La Jolla, California, United States, 92037
Stanford University Medical Center
Palo Alto, California, United States, 94305
UCSF Medical Center
San Francisco, California, United States, 94143
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
University of Colorado HSC
Denver, Colorado, United States, 80262
United States, Illinois
Rush Heart Institute, Center for Pulmonary Heart Disease
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55095
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
Actelion
Investigators
Study Director: Henry Hsu, M.D. CoTherix
More Information
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Publications:

ClinicalTrials.gov Identifier: NCT00086463     History of Changes
Other Study ID Numbers: STEP STUDY
STEP
Pulmonary Hypertension
Pulmonary Artery
Cotherix
First Posted: July 5, 2004    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011

Keywords provided by Actelion:
STEP
PAH
iloprost
inhalation
prostacyclin

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
 Bosentan
Iloprost
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents