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

This study has been terminated.

( Terminated due to slow enrollment )

Study NCT00302211 Information provided by Actelion

First Received on March 10, 2006. Last Updated on May 12, 2011 History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
STARTED	26 ^[1]	27 ^[2]	14 ^[3]
COMPLETED	23	25	10
NOT COMPLETED	3	2	4
Withdrawal by Subject	2	1	0
Adverse Event	0	0	3
Investigator's judgement	1	0	0
Disease progression	0	1	1

[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

	OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan	OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan
STARTED	26 ^[1]	32 ^[2]
COMPLETED	18	24
NOT COMPLETED	8	8
Withdrawal by Subject	3	3
Adverse Event	1	0
Investigator's judgement	1	0
Disease progression	1	2
Death	1	1
Lost to Follow-up	0	1
PH requiring lung transplant	0	1
Termination of the study by the sponsor	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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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

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 ]

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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

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Written permission to publish results must be obtained in advance from Actelion (formerly CoTherix). Manuscript of any proposed publication must be sent to Actelion at least 30 days in advance of the submission date. Actelion will inform in writing of any objection of specific content in the proposed publication.In addition, the institution shall either delete disclosure of all potentially patentable inventions or delay submission of the proposed publication for up to 90 days.

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