The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension (VISION)
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ClinicalTrials.gov Identifier: NCT00302211 |
Recruitment Status :
Terminated
(Terminated due to slow enrollment)
First Posted : March 14, 2006
Results First Posted : August 13, 2010
Last Update Posted : April 16, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Hypertension | Drug: Inhaled Iloprost (5 μg) Drug: Inhaled Placebo Drug: Sildenafil Drug: Bosentan | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 1, 2006 |
Actual Primary Completion Date : | December 1, 2007 |
Actual Study Completion Date : | July 1, 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: DB inhaled iloprost 6x/day
inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period
|
Drug: Inhaled Iloprost (5 μg)
iloprost inhalation solution (Ventavis) (5 μg) Drug: Sildenafil oral sildenafil (dosage between 60 and 300 mg/day) Drug: Bosentan oral bosentan (dosage between 62.5 and 125 mg BID) |
Experimental: DB inhaled iloprost 4x/day
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
|
Drug: Inhaled Iloprost (5 μg)
iloprost inhalation solution (Ventavis) (5 μg) Drug: Inhaled Placebo inhaled placebo Drug: Sildenafil oral sildenafil (dosage between 60 and 300 mg/day) Drug: Bosentan oral bosentan (dosage between 62.5 and 125 mg BID) |
Placebo Comparator: DB inhaled placebo 6x/day
Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
|
Drug: Inhaled Placebo
inhaled placebo Drug: Sildenafil oral sildenafil (dosage between 60 and 300 mg/day) Drug: Bosentan oral bosentan (dosage between 62.5 and 125 mg BID) |
Experimental: OL inhaled iloprost 6x/day
Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
|
Drug: Inhaled Iloprost (5 μg)
iloprost inhalation solution (Ventavis) (5 μg) |
Experimental: OL inhaled iloprost 4x/day
Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
|
Drug: Inhaled Iloprost (5 μg)
iloprost inhalation solution (Ventavis) (5 μg) |
- 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.
- Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16 [ Time Frame: 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.
- Time to Clinical Worsening [ Time Frame: 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.
- Number of Participants With Any Adverse Events [ Time Frame: 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.

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Ages Eligible for Study: | 12 Years to 85 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

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): NCT00302211

Principal Investigator: | Nazzareno Galie, MD | Istituto Malattie Apparato Cardio Univ di Bologna |
Responsible Party: | Actelion |
ClinicalTrials.gov Identifier: | NCT00302211 |
Other Study ID Numbers: |
C200-006 |
First Posted: | March 14, 2006 Key Record Dates |
Results First Posted: | August 13, 2010 |
Last Update Posted: | April 16, 2019 |
Last Verified: | March 2019 |
PAH Pulmonary Arterial Hypertension |
Hypertension, Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Bosentan Sildenafil Citrate Iloprost |
Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents Antihypertensive Agents Endothelin Receptor Antagonists Platelet Aggregation Inhibitors |