- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355380
Efficacy of Ventavis Used in Real-life Setting. (SPHERA)
October 16, 2017 updated by: Bayer
The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.
Typical clinical measures and quality of life will be prospectively followed in 12 months period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Many Locations, Poland
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.
Description
Inclusion Criteria:
- Pulmonary arterial hypertension in WHO functional class III or IV
- Age 18+
- Patients newly treated with Ventavis or switched from sildenafil
Exclusion Criteria:
- Retrospective documentation is not allowed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Drug (incl. Placebo)
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Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes of the exercise capacity as measured by 6-minutes walking distance
Time Frame: 3, 6, 9 and 12 months vs. baseline
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3, 6, 9 and 12 months vs. baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes of depression score over time
Time Frame: 3, 6, 9 and 12 months vs. baseline
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3, 6, 9 and 12 months vs. baseline
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Changes of functional capacity as measured by WHO classification system
Time Frame: 3, 6, 9 and 12 months vs. baseline
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3, 6, 9 and 12 months vs. baseline
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Changes of pulmonary haemodynamics
Time Frame: 3, 6, 9 and 12 months vs. baseline
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3, 6, 9 and 12 months vs. baseline
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Changes of serum level of natriuretic peptide B
Time Frame: 3, 6, 9 and 12 months vs. baseline
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3, 6, 9 and 12 months vs. baseline
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Changes of Quality of Life score
Time Frame: 3, 6, 9 and 12 months vs. baseline
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3, 6, 9 and 12 months vs. baseline
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Changes in cardiac echo parameters
Time Frame: 3, 6, 9 and 12 months vs. baseline
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3, 6, 9 and 12 months vs. baseline
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Number of patients with treatment-emergent adverse events
Time Frame: Up to 12 months
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Up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2010
Primary Completion (Actual)
April 28, 2016
Study Completion (Actual)
September 22, 2016
Study Registration Dates
First Submitted
May 17, 2011
First Submitted That Met QC Criteria
May 17, 2011
First Posted (Estimate)
May 18, 2011
Study Record Updates
Last Update Posted (Actual)
October 17, 2017
Last Update Submitted That Met QC Criteria
October 16, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15308
- VE1010PL (Other Identifier: Company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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