Trial Condition(s):
Hypertension, Pulmonary
non-interventional, postauthorization safety study of Ventavis for Pulmonary Arterial Hypertension (PAH)
Bayer Identifier:
17941
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Recruitment Complete
Trial Purpose
This study is collecting post-marketing information on
the safety and effectiveness of Ventavis under the
routine clinical practice for patients with PAH
Inclusion Criteria
- Patients diagnosed with PAH - Patients for whom the decision to initiate treatment with Ventavis was made as per investigator’s routine treatment practice.
Exclusion Criteria
- N/A
Trial Summary
Enrollment Goal
295
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations many locations many locations, Japan | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with treatment emergent adverse events (TEAE) of special interest.TEAE of special interest: - Hypotension - Syncope - Local irritation - Bleeding events - Thrombocytopenia - TachycardiaTimeframe: Up to 5 years
- Number of participants with adverse drug reactionTimeframe: Up to 5 years
Secondary Outcome
- Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 monthsTimeframe: Baseline and 3 months,Baseline and 12 months,
- Change from baseline in 6-Minute Walking Distance after 3 and 12 monthsTimeframe: Baseline and 3 months,Baseline and 12 months
- Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 monthsTimeframe: 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.Timeframe: Baseline and 3 months,Baseline and 12 months
- Change from baseline in WHO functional class after 3 and 12 monthsTimeframe: Baseline and 3 months,Baseline and 12 months,
- Time to Clinical WorseningThe 1st occurrence date of one of the following events is recorded and used for the calculation of time to clinical worsening: -Death (all-cause mortality), -Heart/lung transplantation, -Atrial Septostomy, -Hospitalization due to persistent worsening of Pulmonary Hypertension (PH), -Start of new PH specific treatment or modification of a preexisting Prostacycline analogues treatment except Ventavis due to worsening PH, -Persistent decrease in 6MWD due to worsening PH, -Persistent worsening of WHO functional class due to deterioration of PHTimeframe: Up to 5 years
Additional Information
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