Pulmonary Arterial HypertensionPhase 2NCT00086463
Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)
A Phase 2 study of Pulmonary Arterial Hypertension and Ayerza Syndrome, run by Actelion at 17 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Ayerza Syndrome, Pulmonary Hypertension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 2004to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Rush Heart Institute, Center for Pulmonary Heart Disease
Chicago, Illinois, 60612
The Children's Hospital
Denver, Colorado, 80218
University of Colorado HSC
Denver, Colorado, 80262
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
UCSD Medical Center
La Jolla, California, 92037
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Medical Center
New York, New York, 10032
Stanford University Medical Center
Palo Alto, California, 94305
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55095
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
UCSF Medical Center
San Francisco, California, 94143
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH
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.
- Being tested
- Iloprost or placebo
- Keywords
- STEP, PAH, iloprost, inhalation, prostacyclin
- Medical subject headings
- Pulmonary Arterial Hypertension, Familial Primary Pulmonary Hypertension, Hypertension, Pulmonary, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost or placeboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2004 (estimated)
- Study startJun 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henry Hsu, M.D., Study director, CoTherix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086463
- Sponsor's protocol ID
- STEP STUDY
- Other IDs
- STEP, Pulmonary Hypertension, Pulmonary Artery, Cotherix
- Status last verified
- Mar 2011
- First submitted
- 1 Jul 2004
- Last updated
- 1 Apr 2011
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH
- ClinicalTrials.gov ID
- NCT00086463
- Acronym / sponsor ID
- STEP STUDY
- Keywords
- STEP, PAH, iloprost, inhalation, prostacyclin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 5 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost or placebo | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2011.
- Background: PubMed 12151469Olschewski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Hsu, M.D. study director
CoTherix
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Pulmonary Arterial Hypertension and Ayerza Syndrome, run by Actelion at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00086463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2011.