Hypertension, PulmonaryIVENTNCT01971450
Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
An observational study of Hypertension, Pulmonary, run by Bayer at 1 site in Russia.
Trial summary
Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Iloprost (Ventavis, BAYQ6256)
- How many people
- 89 participants
- Where
- 1 siteRussia
- Study dates
- 21 Nov 2013to 18 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients ≥ 18 years old with PH, treated with Ventavis and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.
Who may be able to join
- Male and female patients ≥ 18 years old
- Diagnosis of PH
- Planned or current treatment with Ventavis (not more than 6 month)
Who cannot join
- Contraindications for the use of Ventavis in accordance with the local product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Iloprost (Ventavis, BAYQ6256)
- Keywords
- Non-interventional, Ventavis, Iloprost, Pulmonary hypertension, Compliance, Russian Federation
- Medical subject headings
- Hypertension, Pulmonary, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost (Ventavis, BAYQ6256)Drug
| Study group | Role | What they receive |
|---|---|---|
| Iloprost | The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion. Receives: Drug: Iloprost (Ventavis, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days without any drug administration at all
Measured: Up to 12 months
Number of fully inhaled doses in relation to the total number of inhalations per day
Measured: Up to 12 months
Number of missed doses per day as recommended
Measured: Up to 12 months
Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label
Measured: Up to 12 months
Secondary outcomes (14)
6 minute walking distance test (MWDT) value
Measured: Up to 12 months
Score on dyspnea Borg CR (category ratio) 10 scale
Measured: Up to 12 months
Patients' quality of life, assessed by validated questionnaire
Measured: Up to 12 months
Assessment of the structural changes in the lungs using X-ray examination of the lungs
Measured: Up to 12 months
Assessment of the structural changes in the lungs using spirography
Measured: Up to 12 months
Assessment of lung haemodynamics using the data of echocardiography
Measured: Up to 12 months
Assessment of lung haemodynamics using the data of catheterization
Measured: Up to 12 months
Reason for omission of inhalation as assessed by the physician
Measured: Up to 12 months
Concomitant medication for other indications than pulmonary hypertension
Measured: Up to 12 months
Number of participants with adverse events (AEs)
Measured: Up to 12 months
Severity of AEs
Measured: Up to 12 months
AE relation to treatment
Measured: Up to 12 months
AE treatment
Measured: Up to 12 months
AE outcomes
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study start21 Nov 2013
- Primary completion28 Jun 2017
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971450
- Sponsor's protocol ID
- 16777
- Other IDs
- VE1311RU
- Acronym
- IVENT
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2013
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01971450
- Acronym / sponsor ID
- IVENT / 16777
- Conditions
- Hypertension, Pulmonary
- Keywords
- Non-interventional, Ventavis, Iloprost, Pulmonary hypertension, Compliance, Russian Federation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2013 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iloprost | – | Drug: Iloprost (Ventavis, BAYQ6256)The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients ≥ 18 years old with PH, treated with Ventavis and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.
Key inclusion criteria (3 listed)
- Male and female patients ≥ 18 years old
- Diagnosis of PH
- Planned or current treatment with Ventavis (not more than 6 month)
Key exclusion criteria (1 listed)
- Contraindications for the use of Ventavis in accordance with the local product information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost (Ventavis, BAYQ6256) | Drug | Iloprost |
Primary outcome
Number of days without any drug administration at all
Time frame: Up to 12 months
Number of fully inhaled doses in relation to the total number of inhalations per day
Time frame: Up to 12 months
Number of missed doses per day as recommended
Time frame: Up to 12 months
Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label
Time frame: Up to 12 months
14 secondary outcomes
6 minute walking distance test (MWDT) value
Time frame: Up to 12 months
Score on dyspnea Borg CR (category ratio) 10 scale
Time frame: Up to 12 months
Patients' quality of life, assessed by validated questionnaire
Time frame: Up to 12 months
Assessment of the structural changes in the lungs using X-ray examination of the lungs
Time frame: Up to 12 months
Assessment of the structural changes in the lungs using spirography
Time frame: Up to 12 months
Assessment of lung haemodynamics using the data of echocardiography
Time frame: Up to 12 months
Assessment of lung haemodynamics using the data of catheterization
Time frame: Up to 12 months
Reason for omission of inhalation as assessed by the physician
Time frame: Up to 12 months
Concomitant medication for other indications than pulmonary hypertension
Time frame: Up to 12 months
Number of participants with adverse events (AEs)
Time frame: Up to 12 months
Severity of AEs
Time frame: Up to 12 months
AE relation to treatment
Time frame: Up to 12 months
AE treatment
Time frame: Up to 12 months
AE outcomes
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
Related trials for Hypertension, Pulmonary
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary, run by Bayer at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days without any drug administration at all (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.