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Completed

NCT Number: NCT02825160

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

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

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventavis (Iloprost, BAYQ6256)

Drug

The treatment of Ventavis should comply with the local product information

Primary outcomes

  1. 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

  2. Number of participants with adverse drug reaction

    Time frame: Up to 5 years

Secondary outcomes

  1. Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months

    Time frame: Baseline and 3 months,Baseline and 12 months,

  2. Change from baseline in 6-Minute Walking Distance after 3 and 12 months

    Time frame: Baseline and 3 months,Baseline and 12 months

  3. Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months

    Time frame: Baseline and 3 months,Baseline and 12 months

  4. 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.

    Time frame: Baseline and 3 months,Baseline and 12 months

  5. Change from baseline in WHO functional class after 3 and 12 months

    Time frame: Baseline and 3 months,Baseline and 12 months,

  6. Time to Clinical Worsening

    Time frame: Up to 5 years

    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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2016
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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