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

Bayer

Status and phase: Completed; Phase 3

Conditions: Hypertension, Pulmonary

Treatments: Drug: Ventavis (Iloprost, BAYQ6256)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185315

303045

Follow-up 90419-300180

90570

Details and patient eligibility

About

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

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 71 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Ventavis (Iloprost, BAYQ6256)