Status:

TERMINATED

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

Lead Sponsor:

Actelion

Conditions:

Pulmonary Hypertension

Eligibility:

All Genders

12-85 years

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

67 Patients enrolled

Trial Details

Trial ID

NCT00302211

Start Date

February 1 2006

End Date

July 1 2008

Last Update

February 4 2025

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