check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:
17941
ClinicalTrials.gov Identifier:
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
the safety and effectiveness of Ventavis under the
routine clinical practice for patients with PAH
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
282Trial Dates
August 2016 - September 2023Phase
N/ACould I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | many locations | many 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 - Tachycardiadate_rangeTime Frame:Up to 5 yearsenhanced_encryptionYesSafety Issue:
- Number of participants with adverse drug reactiondate_rangeTime Frame:Up to 5 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 monthsdate_rangeTime Frame:Baseline and 3 months,Baseline and 12 months,enhanced_encryptionNoSafety Issue:
- Change from baseline in 6-Minute Walking Distance after 3 and 12 monthsdate_rangeTime Frame:Baseline and 3 months,Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 monthsdate_rangeTime Frame:Baseline and 3 months,Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in WHO functional class after 3 and 12 monthsdate_rangeTime Frame:Baseline and 3 months,Baseline and 12 months,enhanced_encryptionNoSafety Issue:
- Time to Clinical WorseningThe 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 PHdate_rangeTime Frame:Up to 5 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A