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CompletedNCT00086463Updated Apr 1, 2011

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

A Phase 2 interventional study of Iloprost or placebo in Pulmonary Arterial Hypertension, Ayerza Syndrome and Pulmonary Hypertension, sponsored by Actelion. Completed at 17 sites in United States. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-04-01.

Sponsored by Actelion · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 75 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Pulmonary Arterial Hypertension
  • Ayerza Syndrome
  • Pulmonary Hypertension

Keywords

  • STEP
  • PAH
  • iloprost
  • inhalation
  • prostacyclin
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 60 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
60 participants

Interventions

  • DrugIloprost or placebo
06

Study locations

17 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • UCSD Medical Center
    La Jolla, California 92037, United States
  • Stanford University Medical Center
    Palo Alto, California 94305, United States
  • UCSF Medical Center
    San Francisco, California 94143, United States
  • Harbor-UCLA Medical Center
    Torrance, California 90502, United States
  • The Children's Hospital
    Denver, Colorado 80218, United States
  • University of Colorado HSC
    Denver, Colorado 80262, United States
  • Rush Heart Institute, Center for Pulmonary Heart Disease
    Chicago, Illinois 60612, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Mayo Clinic
    Rochester, Minnesota 55095, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Latter Day Saints Hospital
    Salt Lake City, Utah 84143, United States
07

References and documents

Publications

  • Olschewski H, Simonneau G, Galie N, Higenbottam T, Naeije R, Rubin LJ, Nikkho S, Speich R, Hoeper MM, Behr J, Winkler J, Sitbon O, Popov W, Ghofrani HA, Manes A, Kiely DG, Ewert R, Meyer A, Corris PA, Delcroix M, Gomez-Sanchez M, Siedentop H, Seeger W; Aerosolized Iloprost Randomized Study Group. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med. 2002 Aug 1;347(5):322-9. doi: 10.1056/NEJMoa020204. PubMed 12151469 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00086463
Lead sponsor
Actelion
First posted
Jul 5, 2004
Start date
Jun 2004
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Apr 1, 2011

Study contacts

Henry Hsu, M.D.
study director · CoTherix
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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