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

Phase 3

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Ventavis (Iloprost, BAYQ6256)

• Registration Number: NCT00185315
• Lead Sponsor: Bayer

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.

Study Timeline

• Study Start: 2000-02
• Study Completion: 2005-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-19
• Last Update Posted: 2010-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Ventavis (Iloprost, BAYQ6256)	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Throughout the whole study

Secondary Outcome Measures

Name	Time	Method
Tolerability of treatment	Over a minimum of 24 months