Hypertension, PulmonaryNCT00250640
Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years
An observational study of Hypertension, Pulmonary, run by Bayer at 43 sites in 6 countries.
Trial summary
This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. 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
- 106 participants
- Where
- 43 sitesin 6 countries
- Study dates
- Apr 2005to Jul 2012
- 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: Patients with the disease in scope and the prescription of Ventavis mainly from expert clinics in the participating countries
Who may be able to join
- The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
- Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association)
- No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)
Who cannot join
- Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert)
Trial locations and contacts
43 sites in 6 countries.
43 sites in 6 countries
Germany21 sites
Study site
Berlin, State of Berlin, 12200
Study site
Berlin, State of Berlin, 13353
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Cologne, North Rhine-Westphalia, 50924
Study site
Donaueschingen, Baden-Wurttemberg, 78166
Study site
Dresden, Saxony, 01307
Study site
Erfurt, Thuringia, 99089
Study site
Erlangen, Bavaria, 91054
Study site
Essen, North Rhine-Westphalia, 45147
Study site
Giessen, Hesse, 35392
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20246
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
Heidelberg, Baden-Wurttemberg, 69126
Study site
Homburg/Saar, Saarland, 66421
Study site
Leipzig, Saxony, 04103
Study site
Löwenstein, Baden-Wurttemberg, 74245
Study site
Mönchengladbach, North Rhine-Westphalia, 41069
Study site
München, Bavaria, 80336
Study site
München, Bavaria, 81377
Study site
Regensburg, Bavaria, 93053
Study site
Wuppertal, North Rhine-Westphalia, 42283
France8 sites
Study site
Brest, F-29609
Study site
Clamart, 92141
Study site
Lille, 59037
Study site
Lyon, 69394
Study site
Pessac, 33604
Study site
Reims, 51092
Study site
Strasbourg, 67091
Study site
Vandœuvre-lès-Nancy, 54500
Italy4 sites
Study site
Bologna, 40138
Study site
Pavia, 27100
Study site
Pisa, 56100
Study site
Roma, 00161
Spain4 sites
Study site
Barcelona, Barcelona, 08036
Study site
Barcelona, 08035
Study site
Córdoba, Córdoba, 14004
Study site
Madrid, 28041
United Kingdom4 sites
Study site
Glasgow, G11 6NT
Study site
London, NW3 2PF
Study site
Newcastle upon Tyne, NE7 7DN
Study site
Sheffield, S10 2JF
Portugal2 sites
Study site
Coimbra, Coimbra District, 3000-075
Study site
Lisbon, 1150-291
About this study
Official title: Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years
This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Iloprost (Ventavis, BAYQ6256)
- Keywords
- Primary Pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost (Ventavis, BAYQ6256)Drug
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Iloprost (Ventavis, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline.
Measured: Month 3 Visit
Secondary outcomes (6)
Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL.
Measured: all scheduled visits (Study period is min. 2 years and max. 4 years)
Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline.
Measured: all scheduled visits (Study period is min. 2 years and max. 4 years)
Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.
Measured: all scheduled visits (Study period is min. 2 years and max. 4 years)
The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.
Measured: all scheduled visits (Study period is min. 2 years and max. 4 years)
Other safety variable
Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation
Measured: At all scheduled visits (Study period is min. 2 years and max. 4 years)
Other safety variables (optional assessment)
Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses
Measured: At all scheduled visits (Study period is min. 2 years and max. 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2012
- Study completionJul 2012
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
- 106 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
- NCT00250640
- Sponsor's protocol ID
- 91430
- Other IDs
- 308120
- Status last verified
- Jan 2015
- First submitted
- 7 Nov 2005
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years
- ClinicalTrials.gov ID
- NCT00250640
- Acronym / sponsor ID
- 91430
- Conditions
- Hypertension, Pulmonary
- Keywords
- Primary Pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Nov 2005 (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 an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Iloprost (Ventavis, BAYQ6256) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the disease in scope and the prescription of Ventavis mainly from expert clinics in the participating countries
Key inclusion criteria (3 listed)
- The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
- Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association)
- No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)
Key exclusion criteria (1 listed)
- Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert)
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)The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet | Drug | Group 1 |
Primary outcome
The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline.
Time frame: Month 3 Visit
6 secondary outcomes
Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL.
Time frame: all scheduled visits (Study period is min. 2 years and max. 4 years)
Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline.
Time frame: all scheduled visits (Study period is min. 2 years and max. 4 years)
Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.
Time frame: all scheduled visits (Study period is min. 2 years and max. 4 years)
The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.
Time frame: all scheduled visits (Study period is min. 2 years and max. 4 years)
Other safety variable
Time frame: At all scheduled visits (Study period is min. 2 years and max. 4 years)
Other safety variables (optional assessment)
Time frame: At all scheduled visits (Study period is min. 2 years and max. 4 years)
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 2 Feb 2015.
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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
43 sites in 6 countries: 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 43 sites in 6 countries.
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 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Germany, France, Italy, Spain, United Kingdom and 1 more country. 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?
The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline. (time frame: Month 3 Visit). 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 2 Feb 2015.