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CompletedNCT00185315Updated Apr 20, 2010

Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension

A Phase 3 interventional study of Ventavis (Iloprost, BAYQ6256) in Hypertension, Pulmonary, sponsored by Bayer. Completed at 16 sites in 7 countries. Open to participants aged 18 Years to 71 Years. Per ClinicalTrials.gov, last updated 2010-04-20.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
71
Allocation
Non-randomized
Ages
18 Years to 71 Years
Sex
All
01

Study summary

The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

Read the detailed description

This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

02

Conditions studied

  • Hypertension, Pulmonary
03

In context

Hypertension, Pulmonary

1,119 studies on the registry are indexed under Hypertension, Pulmonary; 236 are open to participants now.

This study's enrollment of 71 is above the median of 35 across 659 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 71 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Completion of the 12-week treatment period of the predecessor Schering study 97218/300180
  • Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient
  • Negative pregnancy test for females

Exclusion criteria

Exclusion Criteria:

  • Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Ventavis (Iloprost, BAYQ6256)

Interventions

06

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: Throughout the whole study

Secondary outcomes

  1. Tolerability of treatment

    Time frame: Over a minimum of 24 months

07

Study locations

16 sites
  • Brussels, 1070, Belgium
  • Leuven, 3000, Belgium
  • Clamart, 92141, France
  • Grenoble, 38043, France
  • Lille, 59037, France
  • Reims, 51092, France
  • Tours, 37044, France
  • Bologna, BO 40138, Italy
  • Montescano, Pavia 27040, Italy
  • Pisa, PI 56100, Italy
  • Amsterdam, 1081 HV, Netherlands
  • Warsaw, 01138, Poland
  • Coimbra, 3000-076, Portugal
  • Vila Nova de Gaia, 4434-506, Portugal
  • Barcelona, Barcelona 08035, Spain
  • Madrid, Madrid 28041, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00185315
Lead sponsor
Bayer
First posted
Sep 16, 2005
Start date
Feb 2000
Completion
Aug 2005
Last update
Apr 20, 2010

Study contacts

Bayer Study Director
study director · Bayer
View the source record on ClinicalTrials.gov ↗

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