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

April 19, 2010 updated by: Bayer

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1070
      • Leuven, Belgium, 3000
  • France
      • Clamart Cedex, France, 92141
      • Grenoble Cedex 9, France, 38043
      • Lille, France, 59037
      • Reims, France, 51092
      • Tours Cedex, France, 37044
  • Italy
    • BO
      • Bologna, BO, Italy, 40138
    • PI
      • Pisa, PI, Italy, 56100
    • Pavia
      • Montescano, Pavia, Italy, 27040
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
  • Poland
      • Warszawa, Poland, 01138
  • Portugal
      • Coimbra, Portugal, 3000-076
      • Vila Nova de Gaia, Portugal, 4434-506
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Ventavis (Iloprost, BAYQ6256)
Inhaled iloprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Throughout the whole study
Throughout the whole study

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability of treatment
Time Frame: Over a minimum of 24 months
Over a minimum of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

April 20, 2010

Last Update Submitted That Met QC Criteria

April 19, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90570
  • 303045
  • Follow-up 90419-300180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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