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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-01

Study Completion Date

2008-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DB inhaled iloprost 6x/day

inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period

Group Type EXPERIMENTAL

Inhaled Iloprost (5 μg)

Intervention Type DRUG

iloprost inhalation solution (Ventavis) (5 μg)

Sildenafil

Intervention Type DRUG

oral sildenafil (dosage between 60 and 300 mg/day)

Bosentan

Intervention Type DRUG

oral bosentan (dosage between 62.5 and 125 mg BID)

DB inhaled iloprost 4x/day

Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period

Group Type EXPERIMENTAL

Inhaled Iloprost (5 μg)

Intervention Type DRUG

iloprost inhalation solution (Ventavis) (5 μg)

Inhaled Placebo

Intervention Type DRUG

inhaled placebo

Sildenafil

Intervention Type DRUG

oral sildenafil (dosage between 60 and 300 mg/day)

Bosentan

Intervention Type DRUG

oral bosentan (dosage between 62.5 and 125 mg BID)

DB inhaled placebo 6x/day

Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period

Group Type PLACEBO_COMPARATOR

Inhaled Placebo

Intervention Type DRUG

inhaled placebo

Sildenafil

Intervention Type DRUG

oral sildenafil (dosage between 60 and 300 mg/day)

Bosentan

Intervention Type DRUG

oral bosentan (dosage between 62.5 and 125 mg BID)

OL inhaled iloprost 6x/day

Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period

Group Type EXPERIMENTAL

Inhaled Iloprost (5 μg)

Intervention Type DRUG

iloprost inhalation solution (Ventavis) (5 μg)

OL inhaled iloprost 4x/day

Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period

Group Type EXPERIMENTAL

Inhaled Iloprost (5 μg)

Intervention Type DRUG

iloprost inhalation solution (Ventavis) (5 μg)

Interventions

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Inhaled Iloprost (5 μg)

iloprost inhalation solution (Ventavis) (5 μg)

Intervention Type DRUG

Inhaled Placebo

inhaled placebo

Intervention Type DRUG

Sildenafil

oral sildenafil (dosage between 60 and 300 mg/day)

Intervention Type DRUG

Bosentan

oral bosentan (dosage between 62.5 and 125 mg BID)

Intervention Type DRUG

Eligibility Criteria

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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.

* Additional PAH medications added within the past 12 weeks.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No