Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 282
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment emergent adverse events (TEAE) of special interest.
Study Overview
Brief Summary
This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Ventavis
Ventavis treatment group
Intervention: Ventavis (Iloprost, BAYQ6256) (Drug)
Outcomes
Primary Outcomes
Number of participants with treatment emergent adverse events (TEAE) of special interest.
Time Frame: Up to 5 years
TEAE of special interest: * Hypotension * Syncope * Local irritation * Bleeding events * Thrombocytopenia * Tachycardia
Number of participants with adverse drug reaction
Time Frame: Up to 5 years
Secondary Outcomes
- 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 tricuspid regurgitation pressure gradient (TRPG) 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)
- 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 WHO functional class after 3 and 12 months(Baseline and 3 months,Baseline and 12 months,)
- Time to Clinical Worsening(Up to 5 years)