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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

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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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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Information from the National Library of Medicine

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
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Sponsors and Collaborators
Actelion
Investigators
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Study Director: Henry Hsu, M.D. CoTherix
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00086463    
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:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents