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

NCT00302211 | Terminated Phase 3 Results

• 1 other identifier: C200-006
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Hypertension

Keywords

PAH; Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period

  The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline.

  Day 1 and Week 16

Secondary Outcomes (2)

• Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16

  Day 1 and Week 16

• Time to Clinical Worsening

  Week 16 and Week 48

Other Outcomes (1)

• Number of Participants With Any Adverse Events

  From Day 1 to Week 16 and Week 48

Study Arms (5)

DB inhaled iloprost 6x/day

EXPERIMENTAL

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

Drug: Inhaled Iloprost (5 μg); Drug: Sildenafil; Drug: Bosentan

DB inhaled iloprost 4x/day

EXPERIMENTAL

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

Drug: Inhaled Iloprost (5 μg); Drug: Inhaled Placebo; Drug: Sildenafil; Drug: Bosentan

DB inhaled placebo 6x/day

PLACEBO COMPARATOR

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

Drug: Inhaled Placebo; Drug: Sildenafil; Drug: Bosentan

OL inhaled iloprost 6x/day

EXPERIMENTAL

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

Drug: Inhaled Iloprost (5 μg)

OL inhaled iloprost 4x/day

EXPERIMENTAL

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

Drug: Inhaled Iloprost (5 μg)

Interventions

Inhaled Iloprost (5 μg) DRUG

iloprost inhalation solution (Ventavis) (5 μg)

DB inhaled iloprost 4x/day; DB inhaled iloprost 6x/day; OL inhaled iloprost 4x/day; OL inhaled iloprost 6x/day

Inhaled Placebo DRUG

inhaled placebo

DB inhaled iloprost 4x/day; DB inhaled placebo 6x/day

Sildenafil DRUG

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

DB inhaled iloprost 4x/day; DB inhaled iloprost 6x/day; DB inhaled placebo 6x/day

Bosentan DRUG

oral bosentan (dosage between 62.5 and 125 mg BID)

DB inhaled iloprost 4x/day; DB inhaled iloprost 6x/day; DB inhaled placebo 6x/day

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 12-85 years; of either gender.
• Confirmed PAH due to idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH).
• minute walk distance (6-MWD) between 100-450 meters at screening.
• On a stable dose of sildenafil, with or without bosentan.

You may not qualify if:

• 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.
• Additional PAH medications added within the past 12 weeks.

Sponsors & Collaborators

• Actelion: lead

Related Links

• CoTherix Clinical Development

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

Sildenafil Citrate; Bosentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzenesulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrimidines

Limitations and Caveats

Primary purpose was to evaluate the efficacy of iloprost in PAH patients. Due to slow recruitment only 67 of the 180 participants planned were enrolled. Consequently efficacy results are not meaningful and no statistical analyses could be performed.

Results Point of Contact

• Title: Gary Palmer SVP, US Medical Affairs
• Organization: Actelion Pharmaceuticals US, Inc.

650-624-6900

Study Officials

• Nazzareno Galie, MD

  Istituto Malattie Apparato Cardio Univ di Bologna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: July 1, 2008
• Last Updated: February 4, 2025
• Results First Posted: August 13, 2010

Record last verified: 2025-01