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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
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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Brief 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). 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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Inhaled Iloprost (5 μg) Drug: Inhaled Placebo Drug: Sildenafil Drug: Bosentan Phase 3

Study Design
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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

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Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Actelion
Investigators
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Principal Investigator: Nazzareno Galie, MD Istituto Malattie Apparato Cardio Univ di Bologna
More Information
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Additional Information:

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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
Keywords provided by Actelion:
PAH
Pulmonary Arterial Hypertension
Additional relevant MeSH terms:
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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