Clinical trial NCT02825160: Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)
Official title: Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Iloprost
Ventavis
Prostacycline analogue
Pulmonary arterial hypertension
Japan
Post-marketing surveillance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 282
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment emergent adverse events (TEAE) of special interest.
timeFrame: Up to 5 years
measure: Number of participants with adverse drug reaction
timeFrame: Up to 5 years
Secondary outcomes:
measure: Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months
timeFrame: Baseline and 3 months,Baseline and 12 months,
measure: Change from baseline in 6-Minute Walking Distance after 3 and 12 months
timeFrame: Baseline and 3 months,Baseline and 12 months
measure: Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months
timeFrame: Baseline and 3 months,Baseline and 12 months
measure: 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
measure: Change from baseline in WHO functional class after 3 and 12 months
timeFrame: Baseline and 3 months,Baseline and 12 months,
measure: Time to Clinical Worsening
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: