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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

April 30, 2007

Start Date ^†

February 2000

Current Primary Outcome Measures ^†

Adverse events

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00185315 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Tolerability of treatment over a minimum of 24 months

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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.

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^†

Pulmonary Hypertension

Intervention ^†

Drug: Inhaled iloprost

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00185315

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Bayer

Collaborators ^††

Investigators ^†

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

T. +49 30 468 11800

Information Provided By

Bayer

Verification Date

February 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.