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This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH
This local, prospective, non-interventional, company sponsored, multi-center, single-cohort study includes patients treated with Ventavis for PAH. A total of 270 patients (valid for safety analysis) is planned to be enrolled in 5 years. Target population is patients with PAH diagnosis. This study is performed as an all-patient investigation, therefore all patients who receive Ventavis treatment for PAH need to be registered. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Ventavis treatment. In addition, the extension observation will be carried out as long as Ventavis treatment continues or at most for more 4 years. The standard observation points are 3 month and
1 to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventavis | Ventavis treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventavis (Iloprost, BAYQ6256) | Drug | The treatment of Ventavis should comply with the local product information |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAE) of special interest. | TEAE of special interest:
| Up to 5 years |
| Number of participants with adverse drug reaction | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months | Baseline and 3 months,Baseline and 12 months, | |
| Change from baseline in 6-Minute Walking Distance after 3 and 12 months | Baseline and 3 months,Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
- N/A
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Study population includes PAH patients treated with Ventavis. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Ventavis for PAH need to be registered in principle, until the target number of patients reached.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Japan |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months | Baseline and 3 months,Baseline and 12 months |
| Change in blood concentration from baseline in brain natriuretic peptide / N-terminal pro-brain natriuretic peptide (BPN/NT-pro BNP) after 3 and 12 months. | Baseline and 3 months,Baseline and 12 months |
| Change from baseline in WHO functional class after 3 and 12 months | Baseline and 3 months,Baseline and 12 months, |
| Time to Clinical Worsening | The 1st occurrence date of one of the following events is recorded and used for the calculation of time to clinical worsening:
| Up to 5 years |
| D002318 |
| Cardiovascular Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |