Hypertension, PulmonaryPhase 2NCT00414687
Aerosolized Randomized Iloprost Study II (AIR - II) Long-Term Safety, Tolerability, and Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension
A Phase 2 study testing Ventavis (Iloprost, BAYQ6256) in people with Hypertension, Pulmonary, run by Bayer.
Trial summary
The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Ventavis (Iloprost, BAYQ6256)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to May 2001
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients
- Secondary pulmonary hypertension
- Mean pulmonary artery pressure equal or above 40 mmHg or primary pulmonary hypertension with a pressure equal or above 30 mmHg while resting during appropriate conventional treatment
- Written informed consent after having been duly informed about all diagnostic and therapeutic measures involved in the study
Who cannot join
- Clinical Instability at baseline
- Pulmonary venous obstruction
- Global respiratory insufficiency
- Obstructive ventilation disorders, Interstitial pulmonary disease
- Cerebrovascular events
- Myocardial infarction or major cardiac surgery within 3 months prior to baseline
Show all 15Show fewer
- Bleeding disorders or bleeding risk
- Severe hepatic insufficiency or renal insufficiency
- Malignant diseases
- HIV positive
- Pregnancy, female patients of child-bearing potential without adequate contraception and nursing mothers
- Congenital or acquired valvular defects and myocardial function disorders not related to pulmonary hypertension
- Prior pulmonary embolism
- Collagenosis
- Pulmonary arterial or valvular stenosis
About this study
Official title: An Explorative, Open-Label, Multicenter, Randomized, Parallel-Group Comparative Study of Safety, Tolerability, and the Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension Over 2 Years
The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Ventavis (Iloprost, BAYQ6256)
- Keywords
- Primary or secondary Pulmonary hypertension, Iloprost, Inhaled, Long-term treatment
- Medical subject headings
- Hypertension, Pulmonary, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventavis (Iloprost, BAYQ6256)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ventavis (Iloprost, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange
Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange
Secondary outcomes (7)
Overall clinical tolerability of the long-term use of iloprost aerosol
Serious Adverse Events and deaths
Effect of long-term administration of inhaled iloprost on mortality and transplantation
Exercise capacity
Acute effect of inhaled iloprost on hemodynamics and gas exchange
Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
Quality of Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startJul 1998
- Study completionMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414687
- Sponsor's protocol ID
- 90427
- Other IDs
- 300341
- Status last verified
- May 2009
- First submitted
- 20 Dec 2006
- Last updated
- 15 May 2009
- Results posted
- No
Publications
Olschewski H, Hoeper MM, Behr J, Ewert R, Meyer A, Borst MM, Winkler J, Pfeifer M, Wilkens H, Ghofrani HA, Nikkho S, Seeger W. Long-term therapy with inhaled iloprost in patients with pulmonary hypertension. Respir Med. 2010 May;104(5):731-40. doi: 10.1016/j.rmed.2010.01.008. Epub 2010 Feb 11.
PubMed 20153158
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative, Open-Label, Multicenter, Randomized, Parallel-Group Comparative Study of Safety, Tolerability, and the Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension Over 2 Years
- ClinicalTrials.gov ID
- NCT00414687
- Acronym / sponsor ID
- 90427
- Conditions
- Hypertension, Pulmonary
- Keywords
- Primary or secondary Pulmonary hypertension, Iloprost, Inhaled, Long-term treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Study completion
- May 2001 (actual)
- First posted
- 21 Dec 2006 (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.
The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ventavis (Iloprost, BAYQ6256) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients
- Secondary pulmonary hypertension
- Mean pulmonary artery pressure equal or above 40 mmHg or primary pulmonary hypertension with a pressure equal or above 30 mmHg while resting during appropriate conventional treatment
- Written informed consent after having been duly informed about all diagnostic and therapeutic measures involved in the study
Key exclusion criteria (15 listed)
- Clinical Instability at baseline
- Pulmonary venous obstruction
- Global respiratory insufficiency
- Obstructive ventilation disorders, Interstitial pulmonary disease
- Cerebrovascular events
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 |
|---|---|---|
| Ventavis (Iloprost, BAYQ6256) | Drug | Arm 1 |
Primary outcome
Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange
Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange
7 secondary outcomes
Overall clinical tolerability of the long-term use of iloprost aerosol
Serious Adverse Events and deaths
Effect of long-term administration of inhaled iloprost on mortality and transplantation
Exercise capacity
Acute effect of inhaled iloprost on hemodynamics and gas exchange
Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
Quality of Life
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 15 May 2009.
- Derived from this study: PubMed 20153158Olschewski H, Hoeper MM, Behr J, Ewert R, Meyer A, Borst MM, Winkler J, Pfeifer M, Wilkens H, Ghofrani HA, Nikkho S, Seeger W. Long-term therapy with inhaled iloprost in patients with pulmonary hypertension. Respir Med. 2010 May;104(5):731-40. doi: 10.1016/j.rmed.2010.01.008. Epub 2010 Feb 11.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ventavis (Iloprost, BAYQ6256) in people with Hypertension, Pulmonary, run by Bayer.
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 4 inclusion and 15 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 15 May 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00414687, which also lists 1 linked publication.
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 15 May 2009.