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

Open-label, Uncontrolled, Long-term Surveillance Study of Iloprost Aerosol Inhalation Therapy in the Treatment of Patients With Primary or Secondary Pulmonary Hypertension. Follow-up Program for Patients Who Completed 12 Weeks in Study ME97218/300180.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185315

Enrollment

Registered

2005-09-16

Start date

2000-02-29

Completion date

2005-08-31

Last updated

2010-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

Brief 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.

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.

Interventions

DRUGVentavis (Iloprost, BAYQ6256)

Inhaled iloprost

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 71 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame
Adverse events	Throughout the whole study

Secondary

Measure	Time frame
Tolerability of treatment	Over a minimum of 24 months

Countries

Belgium, France, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026