Trial Condition(s):
Hypertension, Pulmonary
Safety follow-up study of inhaled iloprost in patients with pulmonary hypertension
Bayer Identifier:
90570
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Instytut Gruzlicy i Chorob Pluc Warszawa, Poland, 01138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebrón Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU Reims, Hopital Robert Debre REIMS, France, 51092 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Antoine Beclere Clamart Cedex, France, 92141 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Claude-Huriez CHRU Lille, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università di Pisa Pisa, Italy, 56100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Albert Calmette Lille, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Bretonneau Tours Cedex, France, 37044 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vrije Universiteit Medisch Centrum AMSTERDAM, Netherlands, 1081 HV | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations C.H.U. - Hopital Nord Grenoble Cedex 9, France, 38043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università di Bologna Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Medico di Montescano Montescano, Italy, 27040 | Status Completed | Contact Us: E-mail: clinical[email protected] Phone: Not Available |
Locations Centro Hospitalar Vila Nova de Gaia Vila Nova de Gaia, Portugal, 4434-506 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000-076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES, Belgium, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Adverse eventsTimeframe: Throughout the whole study
Secondary Outcome
- Tolerability of treatmentTimeframe: Over a minimum of 24 months
Additional Information
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