Pulmonary Arterial HypertensionSPHERANCT01355380
Efficacy of Ventavis Used in Real-life Setting.
An observational study of Pulmonary Arterial Hypertension, run by Bayer at 1 site in Poland.
Trial summary
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis. Typical clinical measures and quality of life will be prospectively followed in 12 months period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Inhaled iloprost (Ventavis, BAYQ6256)
- How many people
- 55 participants
- Where
- 1 sitePoland
- Study dates
- 5 Aug 2010to 22 Sep 2016
- 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: Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.
Who may be able to join
- Pulmonary arterial hypertension in WHO functional class III or IV
- Age 18+
- Patients newly treated with Ventavis or switched from sildenafil
Who cannot join
- Retrospective documentation is not allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.
Typical clinical measures and quality of life will be prospectively followed in 12 months period.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Inhaled iloprost (Ventavis, BAYQ6256)
- Keywords
- Pulmonary arterial hypertension, Inhaled iloprost, Quality of life
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled iloprost (Ventavis, BAYQ6256)Drug
Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Drug (incl. Placebo) Receives: Drug: Inhaled iloprost (Ventavis, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the exercise capacity as measured by 6-minutes walking distance
Measured: 3, 6, 9 and 12 months vs. baseline
Secondary outcomes (7)
Changes of depression score over time
Measured: 3, 6, 9 and 12 months vs. baseline
Changes of functional capacity as measured by WHO classification system
Measured: 3, 6, 9 and 12 months vs. baseline
Changes of pulmonary haemodynamics
Measured: 3, 6, 9 and 12 months vs. baseline
Changes of serum level of natriuretic peptide B
Measured: 3, 6, 9 and 12 months vs. baseline
Changes of Quality of Life score
Measured: 3, 6, 9 and 12 months vs. baseline
Changes in cardiac echo parameters
Measured: 3, 6, 9 and 12 months vs. baseline
Number of patients with treatment-emergent adverse events
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 posted18 May 2011 (estimated)
- Study start5 Aug 2010
- Primary completion28 Apr 2016
- Study completion22 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- 55 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
- NCT01355380
- Sponsor's protocol ID
- 15308
- Other IDs
- VE1010PL
- Acronym
- SPHERA
- Status last verified
- Oct 2017
- First submitted
- 17 May 2011
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".
- ClinicalTrials.gov ID
- NCT01355380
- Acronym / sponsor ID
- SPHERA / 15308
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary arterial hypertension, Inhaled iloprost, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2010 (actual)
- Primary completion
- 28 Apr 2016 (actual)
- Study completion
- 22 Sep 2016 (actual)
- First posted
- 18 May 2011 (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.
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.
Typical clinical measures and quality of life will be prospectively followed in 12 months period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Inhaled iloprost (Ventavis, BAYQ6256)Drug (incl. Placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.
Key inclusion criteria (3 listed)
- Pulmonary arterial hypertension in WHO functional class III or IV
- Age 18+
- Patients newly treated with Ventavis or switched from sildenafil
Key exclusion criteria (1 listed)
- Retrospective documentation is not allowed
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 |
|---|---|---|
| Inhaled iloprost (Ventavis, BAYQ6256)Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily | Drug | Group 1 |
Primary outcome
Changes of the exercise capacity as measured by 6-minutes walking distance
Time frame: 3, 6, 9 and 12 months vs. baseline
7 secondary outcomes
Changes of depression score over time
Time frame: 3, 6, 9 and 12 months vs. baseline
Changes of functional capacity as measured by WHO classification system
Time frame: 3, 6, 9 and 12 months vs. baseline
Changes of pulmonary haemodynamics
Time frame: 3, 6, 9 and 12 months vs. baseline
Changes of serum level of natriuretic peptide B
Time frame: 3, 6, 9 and 12 months vs. baseline
Changes of Quality of Life score
Time frame: 3, 6, 9 and 12 months vs. baseline
Changes in cardiac echo parameters
Time frame: 3, 6, 9 and 12 months vs. baseline
Number of patients with treatment-emergent adverse events
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 17 Oct 2017.
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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 Pulmonary Arterial Hypertension, run by Bayer at 1 site in Poland.
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 17 Oct 2017. 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 Poland. 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?
Changes of the exercise capacity as measured by 6-minutes walking distance (time frame: 3, 6, 9 and 12 months vs. baseline). 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 17 Oct 2017.