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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00185315 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
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Scientific title:
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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. |
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Date of first enrolment:
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February 2000 |
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Target sample size:
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71 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00185315 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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France
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Italy
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Netherlands
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Poland
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Portugal
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Spain
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
71 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Intervention(s)
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Drug: Ventavis (Iloprost, BAYQ6256)
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Primary Outcome(s)
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Adverse events
[Time Frame: Throughout the whole study]
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Secondary Outcome(s)
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Tolerability of treatment
[Time Frame: Over a minimum of 24 months]
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Secondary ID(s)
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303045
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90570
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Follow-up 90419-300180
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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