Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years
NCT ID: NCT00250640
Last Updated: 2015-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
106 participants
OBSERVATIONAL
2005-04-30
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
NCT00185315
Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
NCT01389271
Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)
NCT01062282
Efficacy of Ventavis Used in Real-life Setting.
NCT01355380
Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)
NCT00882947
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Iloprost (Ventavis, BAYQ6256)
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Iloprost (Ventavis, BAYQ6256)
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association)
* No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brest, , France
Clamart, , France
Lille, , France
Lyon, , France
Pessac, , France
Reims, , France
Strasbourg, , France
Vandœuvre-lès-Nancy, , France
Donaueschingen, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Löwenstein, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Giessen, Hesse, Germany
Bonn, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Mönchengladbach, North Rhine-Westphalia, Germany
Wuppertal, North Rhine-Westphalia, Germany
Homburg/Saar, Saarland, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Erfurt, Thuringia, Germany
Bologna, , Italy
Pavia, , Italy
Pisa, , Italy
Roma, , Italy
Coimbra, Coimbra District, Portugal
Lisbon, , Portugal
Barcelona, Barcelona, Spain
Córdoba, Córdoba, Spain
Barcelona, , Spain
Madrid, , Spain
Glasgow, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
308120
Identifier Type: OTHER
Identifier Source: secondary_id
91430
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.