Trial · NCT00302211
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
NCT00302211, Phase 3, Terminated, Actelion; results first posted 2010-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension. Trials, record NCT00302211. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00302211
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
- NCT number
- NCT00302211
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 67 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Hypertension
- Interventions
- Inhaled Iloprost (5 μg), Inhaled Placebo, Sildenafil, Bosentan
- First posted
- 2006-03-14
- Last updated
- 2025-02-04
- Results first posted
- 2010-08-13
- Limitations and caveats
Primary purpose was to evaluate the efficacy of iloprost in PAH patients. Due to slow recruitment only 67 of the 180 participants planned were enrolled. Consequently efficacy results are not meaningful and no statistical analyses could be performed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period | 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. |
| Secondary | Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16 | Day 1 and 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. |
| Secondary | Time to Clinical Worsening | Week 16 and Week 48 | 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. |
| Other | Number of Participants With Any Adverse Events | From Day 1 to Week 16 and Week 48 | This is the overall number of participants in each group who reported at least one adverse event (i.e., any untoward medical occurrence or unfavorable and unintended sign whether or not considered related to the study drug) with an onset from the first administration of study drug up to the last study visit. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period | Day 1 and Week 16 | Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed. | Meters | MEAN |
| SECONDARY | Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16 | Day 1 and Week 16 | Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Clinical Worsening | Week 16 and Week 48 | Only participants who received at least one dose of study drug and with available data at Week 16 (for the double-blind period) and at Week 48 (for the open-label period) were included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Any Adverse Events | From Day 1 to Week 16 and Week 48 | Safety population: All randomiized subjects who received at least one dose of the study drug | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) During the Double-blind Period | Week 16 | Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had a post-baseline efficacy measure at Week 16. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period | DB Iloprost 6×/Day | 10.1 | Standard Deviation 62.15 | Meters | |
| Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period | DB Iloprost 4×/Day | 29.6 | Standard Deviation 55.17 | Meters | |
| Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period | DB Placebo 6×/Day | -22.0 | Standard Deviation 124.7 | Meters | |
| Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16 | DB Iloprost 6×/Day | 4 | Participants | ||
| Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16 | DB Iloprost 4×/Day | 6 | Participants | ||
| Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16 | DB Placebo 6×/Day | 0 | Participants | ||
| Time to Clinical Worsening | DB Iloprost 6×/Day | 0 | Participants | ||
| Time to Clinical Worsening | DB Iloprost 4×/Day | 1 | Participants | ||
| Time to Clinical Worsening | DB Placebo 6×/Day | 1 | Participants | ||
| Time to Clinical Worsening | OL Iloprost 6x/Day | 2 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Period (New Patients) | STARTED | DB Iloprost 6×/Day | 26 | |
| Double Blind Period (New Patients) | STARTED | DB Iloprost 4×/Day | 27 | |
| Double Blind Period (New Patients) | STARTED | DB Placebo 6×/Day | 14 | |
| Double Blind Period (New Patients) | STARTED | OL Iloprost 6x/Day | 0 | |
| Double Blind Period (New Patients) | STARTED | OL Inhaled Iloprost 4x/Day | 0 | |
| Double Blind Period (New Patients) | COMPLETED | DB Iloprost 6×/Day | 23 | |
| Double Blind Period (New Patients) | COMPLETED | DB Iloprost 4×/Day | 25 | |
| Double Blind Period (New Patients) | COMPLETED | DB Placebo 6×/Day | 10 | |
| Double Blind Period (New Patients) | COMPLETED | OL Iloprost 6x/Day | 0 | |
| Double Blind Period (New Patients) | COMPLETED | OL Inhaled Iloprost 4x/Day | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events715
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arrhythmia | Cardiac disorders | DB Iloprost 6×/Day | 1 | 26 | |
| other | Arrhythmia | Cardiac disorders | DB Iloprost 4×/Day | 0 | 27 | |
| other | Arrhythmia | Cardiac disorders | DB Placebo 6×/Day | 0 | 14 | |
| other | Arrhythmia | Cardiac disorders | OL Iloprost 6x/Day | 0 | 26 | |
| other | Arrhythmia | Cardiac disorders | OL Iloprost 4x/Day | 0 | 32 | |
| other | Atrial Fibrillation | Cardiac disorders | DB Iloprost 6×/Day | 0 | 26 | |
| other | Atrial Fibrillation | Cardiac disorders | DB Iloprost 4×/Day | 1 | 27 | |
| other | Atrial Fibrillation | Cardiac disorders | DB Placebo 6×/Day | 0 | 14 | |
| other | Atrial Fibrillation | Cardiac disorders | OL Iloprost 6x/Day | 0 | 26 | |
| other | Atrial Fibrillation | Cardiac disorders | OL Iloprost 4x/Day | 0 | 32 |
1 to 10 of 715Source ClinicalTrials.gov
See all 715 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB Iloprost 6×/Day | ||
| Total, all-cause mortality | DB Iloprost 4×/Day | ||
| Total, all-cause mortality | DB Placebo 6×/Day | ||
| Total, all-cause mortality | OL Iloprost 6x/Day | ||
| Total, all-cause mortality | OL Iloprost 4x/Day | ||
| Total, other adverse events | DB Iloprost 6×/Day | 24 | 26 |
| Total, other adverse events | DB Iloprost 4×/Day | 22 | 27 |
| Total, other adverse events | DB Placebo 6×/Day | 14 | 14 |
| Total, other adverse events | OL Iloprost 6x/Day | 23 | 26 |
| Total, other adverse events | OL Iloprost 4x/Day | 30 | 32 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00302211
GET https://conductscience.org/api/trials/v1/NCT00302211/results?page=2