Pulmonary HypertensionPhase 3VISIONNCT00302211
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
A Phase 3 study testing Inhaled Iloprost (5 μg), Sildenafil and Bosentan in people with Pulmonary Hypertension, run by Actelion.
Trial summary
The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Inhaled Iloprost (5 μg), Sildenafil and Bosentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2006to 1 Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 12-85 years; of either gender.
- Confirmed PAH due to idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH).
- 6-minute walk distance (6-MWD) between 100-450 meters at screening.
- On a stable dose of sildenafil, with or without bosentan.
Who cannot join
- Any treatment for PAH with prostacyclins, prostacyclin analogues, endothelin-1 antagonists, or phosphodiesterase-5 (PDE-5) inhibitors other than sildenafil within the past 12 weeks.
- Pulmonary hypertension due to conditions other than those stated in inclusion criteria.
- Additional PAH medications added within the past 12 weeks.
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral Sildenafil
The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.
- Conditions
- Pulmonary Hypertension
- Being tested
- Inhaled Iloprost (5 μg), Inhaled Placebo, Sildenafil, Bosentan
- Keywords
- PAH, Pulmonary Arterial Hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Iloprost (5 μg)Drug
iloprost inhalation solution (Ventavis) (5 μg)
Inhaled PlaceboDrug
inhaled placebo
SildenafilDrug
oral sildenafil (dosage between 60 and 300 mg/day)
BosentanDrug
oral bosentan (dosage between 62.5 and 125 mg BID)
| Study group | Role | What they receive |
|---|---|---|
| DB inhaled iloprost 6x/day | Experimental | inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period Receives: Drug: Inhaled Iloprost (5 μg); Drug: Sildenafil; Drug: Bosentan |
| DB inhaled iloprost 4x/day | Experimental | Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period Receives: Drug: Inhaled Iloprost (5 μg); Drug: Inhaled Placebo; Drug: Sildenafil; Drug: Bosentan |
| DB inhaled placebo 6x/day | Placebo comparator | Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period Receives: Drug: Inhaled Placebo; Drug: Sildenafil; Drug: Bosentan |
| OL inhaled iloprost 6x/day | Experimental | Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period Receives: Drug: Inhaled Iloprost (5 μg) |
| OL inhaled iloprost 4x/day | Experimental | Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period Receives: Drug: Inhaled Iloprost (5 μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline.
Measured: Day 1 and Week 16
Secondary outcomes (2)
Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16
This test is used to assess disease severity. Four fucntional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class.
Measured: Day 1 and Week 16
Time to Clinical Worsening
Clinical worsening is defined as one of the following: death due to worsening PAH, receipt of lung or heart-lung transplantation, or atrial septostomy, hospitalization for worsening PAH, any early discontinuation from study during the blinded or open-label phase due to worsening PAH, initiation of additional PAH-specific treatment. Due to insufficient data, time could not be assessed accurately and only number of patients with clinical worsening could be reported.
Measured: Week 16 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study start1 Feb 2006
- Primary completion1 Dec 2007
- Study completion1 Jul 2008
Why it stopped: Terminated due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nazzareno Galie, MD, Principal investigator, Istituto Malattie Apparato Cardio Univ di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302211
- Sponsor's protocol ID
- C200-006
- Acronym
- VISION
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2006
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral Sildenafil
- ClinicalTrials.gov ID
- NCT00302211
- Acronym / sponsor ID
- VISION / C200-006
- Conditions
- Pulmonary Hypertension
- Keywords
- PAH, Pulmonary Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow enrollment
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2006 (actual)
- Primary completion
- 1 Dec 2007 (actual)
- Study completion
- 1 Jul 2008 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Posted 13 Aug 2010
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 multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DB inhaled iloprost 6x/day | Experimental | Drug: Inhaled Iloprost (5 μg), Drug: Sildenafil, Drug: Bosentaninhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period |
| DB inhaled iloprost 4x/day | Experimental | Drug: Inhaled Iloprost (5 μg), Drug: Inhaled Placebo, Drug: Sildenafil, Drug: BosentanInhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period |
| DB inhaled placebo 6x/day | Placebo comparator | Drug: Inhaled Placebo, Drug: Sildenafil, Drug: BosentanInhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period |
| OL inhaled iloprost 6x/day | Experimental | Drug: Inhaled Iloprost (5 μg)Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period |
| OL inhaled iloprost 4x/day | Experimental | Drug: Inhaled Iloprost (5 μg)Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period |
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 12-85 years; of either gender.
- Confirmed PAH due to idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH).
- 6-minute walk distance (6-MWD) between 100-450 meters at screening.
- On a stable dose of sildenafil, with or without bosentan.
Key exclusion criteria (3 listed)
- Any treatment for PAH with prostacyclins, prostacyclin analogues, endothelin-1 antagonists, or phosphodiesterase-5 (PDE-5) inhibitors other than sildenafil within the past 12 weeks.
- Pulmonary hypertension due to conditions other than those stated in inclusion criteria.
- Additional PAH medications added within the past 12 weeks.
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 |
|---|---|---|
| Inhaled Iloprost (5 μg)iloprost inhalation solution (Ventavis) (5 μg) | Drug | DB inhaled iloprost 4x/day, DB inhaled iloprost 6x/day, OL inhaled iloprost 4x/day, OL inhaled iloprost 6x/day |
| Inhaled Placeboinhaled placebo | Drug | DB inhaled iloprost 4x/day, DB inhaled placebo 6x/day |
| Sildenafiloral sildenafil (dosage between 60 and 300 mg/day) | Drug | DB inhaled iloprost 4x/day, DB inhaled iloprost 6x/day, DB inhaled placebo 6x/day |
| Bosentanoral bosentan (dosage between 62.5 and 125 mg BID) | Drug | DB inhaled iloprost 4x/day, DB inhaled iloprost 6x/day, DB inhaled placebo 6x/day |
Primary outcome
Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
Time frame: Day 1 and Week 16
The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline.
2 secondary outcomes
Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16
Time frame: Day 1 and Week 16
Time to Clinical Worsening
Time frame: Week 16 and Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CoTherix Clinical DevelopmentLink provided by the sponsor.
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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.
Nazzareno Galie, MD principal investigator
Istituto Malattie Apparato Cardio Univ di Bologna
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled Iloprost (5 μg), Sildenafil and Bosentan in people with Pulmonary Hypertension, run by Actelion.
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 4 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: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period (time frame: Day 1 and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.