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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

Tracking Information
First Submitted Date  ICMJE March 10, 2006
First Posted Date  ICMJE March 14, 2006
Results First Submitted Date  ICMJE May 27, 2010
Results First Posted Date  ICMJE August 13, 2010
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE February 1, 2006
Actual Primary Completion Date December 1, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2006)
The primary measure will be the change in 6-minute walk distance from baseline, measured after inhalation, following 16 weeks of combination therapy with inhaled iloprost (administered 6 times per day) and sildenafil vs. inhaled placebo plus sildenafil
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 26, 2019)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Inhaled Iloprost (5 μg)
    • Drug: Sildenafil
    • Drug: Bosentan
  • 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
    Interventions:
    • Drug: Inhaled Iloprost (5 μg)
    • Drug: Inhaled Placebo
    • Drug: Sildenafil
    • Drug: Bosentan
  • Placebo Comparator: DB inhaled placebo 6x/day
    Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
    Interventions:
    • Drug: Inhaled Placebo
    • Drug: Sildenafil
    • Drug: Bosentan
  • 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
    Intervention: Drug: Inhaled Iloprost (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
    Intervention: Drug: Inhaled Iloprost (5 μg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 8, 2010)
67
Original Enrollment  ICMJE
 (submitted: March 10, 2006)
180
Actual Study Completion Date  ICMJE July 1, 2008
Actual Primary Completion Date December 1, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00302211
Other Study ID Numbers  ICMJE C200-006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nazzareno Galie, MD Istituto Malattie Apparato Cardio Univ di Bologna
PRS Account Actelion
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP