Back to resultsSafety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
Primary Purpose
Hypertension, Pulmonary
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ventavis (Iloprost, BAYQ6256)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Tolerability of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00185315
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ventavis (Iloprost, BAYQ6256)
Intervention Description
Inhaled iloprost
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
Throughout the whole study
Secondary Outcome Measure Information:
Title
Tolerability of treatment
Time Frame
Over a minimum of 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Clamart Cedex
ZIP/Postal Code
92141
Country
France
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
City
Montescano
State/Province
Pavia
ZIP/Postal Code
27040
Country
Italy
City
Pisa
State/Province
PI
ZIP/Postal Code
56100
Country
Italy
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
City
Warszawa
ZIP/Postal Code
01138
Country
Poland
City
Coimbra
ZIP/Postal Code
3000-076
Country
Portugal
City
Vila Nova de Gaia
ZIP/Postal Code
4434-506
Country
Portugal
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
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Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
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