Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)

Hypertension, Pulmonary Clinical Trial

Official title:

Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825160
• Other study ID #: 17941
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: September 27, 2023

Study information

• Verified date: October 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: September 27, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Ventavis (Iloprost, BAYQ6256)
The treatment of Ventavis should comply with the local product information

Locations

Country	Name	City	State
Japan	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment emergent adverse events (TEAE) of special interest.	TEAE of special interest: Hypotension; Syncope; Local irritation; Bleeding events; Thrombocytopenia; Tachycardia	Up to 5 years
Primary	Number of participants with adverse drug reaction		Up to 5 years
Secondary	Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months		Baseline and 3 months,Baseline and 12 months,
Secondary	Change from baseline in 6-Minute Walking Distance after 3 and 12 months		Baseline and 3 months,Baseline and 12 months
Secondary	Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months		Baseline and 3 months,Baseline and 12 months
Secondary	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
Secondary	Change from baseline in WHO functional class after 3 and 12 months		Baseline and 3 months,Baseline and 12 months,
Secondary	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: 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 PH	Up to 5 years