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Tracking Information | |||||
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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. |
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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. |
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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. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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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 † |
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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. |