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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, 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:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Iloprost Sildenafil Bosentan Sildenafil citrate

U.S. FDA Resources

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 ] [ 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.

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 ] [ 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.

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

Ages Eligible for Study:	12 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:

CoTherix Clinical Development This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Actelion Pharmaceuticals US/Sponsor, Actelion Pharmaceuticals US
ClinicalTrials.gov Identifier:	NCT00302211 History of Changes
Other Study ID Numbers:	C200-006
Study First Received:	March 10, 2006
Results First Received:	May 27, 2010
Last Updated:	May 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

PAH
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Sildenafil
Bosentan
Platelet Aggregation Inhibitors

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Antihypertensive Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013