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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185315
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 20, 2010
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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.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: Ventavis (Iloprost, BAYQ6256) Phase 3

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  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : February 2000
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost

Arm Intervention/treatment
Experimental: Arm 1 Drug: Ventavis (Iloprost, BAYQ6256)
Inhaled iloprost

Primary Outcome Measures :
  1. Adverse events [ Time Frame: Throughout the whole study ]

Secondary Outcome Measures :
  1. Tolerability of treatment [ Time Frame: Over a minimum of 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185315

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

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG Identifier: NCT00185315     History of Changes
Other Study ID Numbers: 90570
Follow-up 90419-300180
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 20, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents