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

This study has been terminated.
(Terminated due to slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302211
First Posted: March 14, 2006
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Actelion
  Purpose
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 Intervention Phase
Pulmonary Hypertension Drug: Iloprost Inhalation Solution (Ventavis) Drug: Inhaled Placebo Drug: Sildenafil Drug: Bosentan Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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 ]
    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.


Secondary Outcome Measures:
  • 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 ]
    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.


Enrollment: 67
Study Start Date: February 2006
Study Completion Date: November 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Inhaled iloprost(5 μg) 6×/day + sildenafil ± bosentan
Drug: Iloprost Inhalation Solution (Ventavis)
iloprost inhalation solution (Ventavis) (5 mcg) 6×/day
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 B
Inhaled iloprost (5 μg) 4×/day + sildenafil ± bosentan
Drug: Iloprost Inhalation Solution (Ventavis)
iloprost inhalation solution (Ventavis) (5 mcg) 4×/day
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: Group C
Inhaled placebo 6×/day + sildenafil ± bosentan
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Senior)
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
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


  Show 34 Study Locations
Sponsors and Collaborators
Actelion
Investigators
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
  More Information

Responsible Party: Actelion Pharmaceuticals US/Sponsor, Actelion Pharmaceuticals US
ClinicalTrials.gov Identifier: NCT00302211     History of Changes
Other Study ID Numbers: C200-006
First Submitted: March 10, 2006
First Posted: March 14, 2006
Results First Submitted: May 27, 2010
Results First Posted: August 13, 2010
Last Update Posted: May 16, 2011
Last Verified: May 2011

Keywords provided by Actelion:
PAH
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Pharmaceutical Solutions
Sildenafil Citrate
Iloprost
Bosentan
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents
Endothelin Receptor Antagonists
Platelet Aggregation Inhibitors