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

Tracking Information

First Received Date ^ICMJE

March 10, 2006

Last Updated Date

August 26, 2009

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00302211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pulmonary Hypertension

Intervention ^ICMJE

Drug: Iloprost Inhalation Solution (Ventavis)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

December 2008

Estimated Primary Completion Date

November 2008 (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

Gender

Both

Ages

12 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00302211

Responsible Party

Actelion Pharmaceuticals US/Sponsor, Actelion Pharmaceuticals US

Study ID Numbers ^ICMJE

C200-006

Study Sponsor ^ICMJE

Actelion

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Robyn J Barst, MD	Steering Committee Advisor
Study Chair:	David B Badesch, MD, FACP, FCCP	Steering Committee Advisor

Information Provided By

Actelion

Verification Date

August 2009

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