Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00086463 |
Recruitment Status :
Completed
First Posted : July 5, 2004
Last Update Posted : April 1, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension Ayerza Syndrome Pulmonary Hypertension | Drug: Iloprost or placebo | Phase 2 |
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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Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

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

Study Director: | Henry Hsu, M.D. | CoTherix |
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 |
STEP PAH iloprost inhalation prostacyclin |
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 |