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
Results First Received: May 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Interventions: Drug: Iloprost Inhalation Solution (Ventavis)
Drug: Inhaled Placebo
Drug: Sildenafil
Drug: Bosentan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
Placebo 6×/Day Plus Sildenafil With or Without Bosentan Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan

Participant Flow for 2 periods

Period 1:   Double Blind Period (New Patients)
    Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan     Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan     Placebo 6×/Day Plus Sildenafil With or Without Bosentan     OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan     OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan  
STARTED     26 [1]   27 [2]   14 [3]   0     0  
COMPLETED     23     25     10     0     0  
NOT COMPLETED     3     2     4     0     0  
Withdrawal by Subject                 2                 1                 0                 0                 0  
Adverse Event                 0                 0                 3                 0                 0  
Investigator's judgement                 1                 0                 0                 0                 0  
Disease progression                 0                 1                 1                 0                 0  
[1] iloprost 6x/day plus sildenafil with or without bosentan
[2] iloprost 4x/day plus sildenafil with or without bosentan
[3] placebo plus sildenafil with or without bosentan

Period 2:   Open Label-Patients From Double-Blind
    Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan     Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan     Placebo 6×/Day Plus Sildenafil With or Without Bosentan     OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan     OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan  
STARTED     0     0     0     26 [1]   32 [2]
COMPLETED     0     0     0     18     24  
NOT COMPLETED     0     0     0     8     8  
Withdrawal by Subject                 0                 0                 0                 3                 3  
Adverse Event                 0                 0                 0                 1                 0  
Investigator's judgement                 0                 0                 0                 1                 0  
Disease progression                 0                 0                 0                 1                 2  
Death                 0                 0                 0                 1                 1  
Lost to Follow-up                 0                 0                 0                 0                 1  
PH requiring lung transplant                 0                 0                 0                 0                 1  
Termination of the study by the sponsor                 0                 0                 0                 1                 0  
[1] 21 patients (pts) in 6x/day DB phase & 5 patients in placebo 6x/day DB phase enrolled in OL 6x/day
[2] 26 pts in 4x/day + placebo 2x/day DB phase & 6 pts in placebo 6x/day DB phase enrolled in OL 4x/day



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Iloprost(5 μg) 6×/Day Plus Sildenafil +/- Bosentan Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
Iloprost 4×/Day + Placebo 2x/Day + Sildenafil ± Bosentan Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
Placebo 6×/Day + Sildenafil +/- Bosentan Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
Total Total of all reporting groups

Baseline Measures
    Iloprost(5 μg) 6×/Day Plus Sildenafil +/- Bosentan     Iloprost 4×/Day + Placebo 2x/Day + Sildenafil ± Bosentan     Placebo 6×/Day + Sildenafil +/- Bosentan     Total  
Number of Participants  
[units: participants]
  26     27     14     67  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     23     17     9     49  
>=65 years     3     10     5     18  
Age  
[units: years]
Mean ± Standard Deviation
  51.9  ± 11.95     56.6  ± 16.27     56.9  ± 11.90     54.8  ± 13.85  
Gender  
[units: participants]
       
Female     20     19     13     52  
Male     6     8     1     15  
Region of Enrollment  
[units: participants]
       
United States     14     15     9     38  
United Kingdom     4     2     1     7  
Spain     0     1     1     2  
Italy     0     1     0     1  
Germany     7     6     3     16  
Austria     1     2     0     3  



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   05/2010   Safety Issue:   No

3.  Other Pre-specified:   Safety Objective   [ Time Frame: Baseline up to 48 weeks ]
Results not yet posted.   Anticipated Posting Date:   05/2010   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Primary purpose was to evaluate the efficacy of iloprost in PAH patients. Slow patient recruitment led to early study closure. In addition there were factors regarding the conduct of the study which preclude conclusions from this limited dataset.  


Results Point of Contact:  
Name/Title: Desilu Villanueva MD, Associate Director, Medical Affairs
Organization: Actelion Pharmaceuticals US, Inc.
phone: 650-624-6900
e-mail: desilu.villanueva@actelion.com


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