Status:

COMPLETED

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

Lead Sponsor:

Bayer

Conditions:

Hypertension, Pulmonary

Eligibility:

All Genders

18-71 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

February 1 2000

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2005

Estimated Enrollment :

71 Patients enrolled

Trial Details

Trial ID

NCT00185315

Start Date

February 1 2000

End Date

August 1 2005

Last Update

April 20 2010

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Brussels, Belgium, 1070

2

Leuven, Belgium, 3000

3

Clamart, France, 92141

4

Grenoble, France, 38043