The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension

This study has been terminated.
(Terminated due to slow enrollment)
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00302211
First received: March 10, 2006
Last updated: May 12, 2011
Last verified: May 2011

March 10, 2006
May 12, 2011
February 2006
December 2007   (final data collection date for primary outcome measure)
Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) in Double-blind, Modified Intent To Treat (MITT) Population [ Time Frame: Day 1 to Week 16 ] [ Designated as safety issue: No ]
Comparing number of Modified Intent to Treat population in double-blind who improved in the 6-minute walk distance - from baseline distance between 100-450 meters. Any increase in walk distance was considered improvement from baseline. The 6-minute walks were measured in meters using a test administrator, a stop watch, and markers to identify the course.
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
Complete list of historical versions of study NCT00302211 on ClinicalTrials.gov Archive Site
Assess the Efficacy of the Addition of Inhaled Iloprost in Patients With PAH Receiving a Stable Dose of Oral Sildenafil [ Time Frame: Baseline Week 16 up to 48 weeks ] [ Designated as safety issue: No ]
The change in 6-minute walk distance (6-MWD) measured after inhalation, following 16 weeks of combination therapy with inhaled iloprost (administered 6 times or 4 times per day) inhaled iloprost plus sildenafil during the open-label extension phase.
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The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pulmonary Hypertension
  • Drug: Iloprost Inhalation Solution (Ventavis)
    iloprost inhalation solution (Ventavis) (5 mcg) 6×/day
  • Drug: Iloprost Inhalation Solution (Ventavis)
    iloprost inhalation solution (Ventavis) (5 mcg) 4×/day
  • Drug: Inhaled Placebo
    inhaled placebo 6×/day (5 mcg)
  • Drug: Sildenafil
    oral sildenafil (dosage between 60 and 300 mg/day)
  • Drug: Bosentan
    oral bosentan (dosage between 62.5 and 125 mg BID)
  • Experimental: Group A
    Inhaled iloprost(5 μg) 6×/day + sildenafil ± bosentan
    Interventions:
    • Drug: Iloprost Inhalation Solution (Ventavis)
    • Drug: Sildenafil
    • Drug: Bosentan
  • Experimental: Group B
    Inhaled iloprost (5 μg) 4×/day + sildenafil ± bosentan
    Interventions:
    • Drug: Iloprost Inhalation Solution (Ventavis)
    • Drug: Sildenafil
    • Drug: Bosentan
  • Placebo Comparator: Group C
    Inhaled placebo 6×/day + sildenafil ± bosentan
    Interventions:
    • Drug: Inhaled Placebo
    • Drug: Sildenafil
    • Drug: Bosentan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
67
November 2009
December 2007   (final data collection date for primary outcome measure)

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
Both
12 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00302211
C200-006
Not Provided
Actelion Pharmaceuticals US/Sponsor, Actelion Pharmaceuticals US
Actelion
Not Provided
Study Chair: Robyn J Barst, MD Steering Committee Advisor
Study Chair: David B Badesch, MD, FACP, FCCP Steering Committee Advisor
Principal Investigator: Ardeschir Ghofrani, MD Medizinische Klinik und Poliklinik II Univer GieBen
Principal Investigator: Nazzareno Galie, MD Istituto Malattie Apparato Cardio Univ di Bologna
Actelion
May 2011

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