check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:infoA unique number for a trial given by Bayer.
17941
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
282The overall number of participants needed for a trial.
Trial Dates info
August 2016 - September 2023Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
N/AA phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Ventavis (Iloprost, BAYQ6256)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Recruiting | many locations | many locations, Japan |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 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 info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
N/AThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.