check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

17941

ClinicalTrials.gov Identifier:

NCT02825160

EudraCT Number:

Not Available

EU CT Number:

Not Available
non-interventional, postauthorization safety study of Ventavis for Pulmonary Arterial Hypertension (PAH)

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

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients diagnosed with PAH
    - Patients for whom the decision to initiate treatment with Ventavis was made as per investigator’s routine treatment practice.
  • - N/A

Trial summary

Enrollment Goal
282
Trial Dates
August 2016 - September 2023
Phase
N/A
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
many locationsmany locations, Japan

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 - Tachycardia
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse drug reaction
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months,
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in 6-Minute Walking Distance after 3 and 12 months
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in WHO functional class after 3 and 12 months
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months,
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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