Pulmonary HypertensionOPTIONNCT01389271
Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
An observational study of Pulmonary Hypertension, run by Bayer at 1 site in Turkey (Türkiye).
Trial summary
This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Ventavis inhaled (Iloprost, BAYQ6256)
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2011to 18 Jun 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: Primary (idiopathic and familial) pulmonary hypertension and PAH secondary to scleroderma without significant interstitial pulmonary disease classified as New York Heart Association (NYHA) functional class III and IV
Who may be able to join
- Patients who has pulmonary hypertension treated with inhaled iloprost older than 18 years old.
- Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
- Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
- Patients who signed written informed consent.
Who cannot join
- Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision;
- Severe arrhythmias;
- Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
- Pulmonary hypertension due to venous occlusive disease.
- Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
- Pregnancy and lactation
- Age below 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.
- Conditions
- Pulmonary Hypertension
- Being tested
- Ventavis inhaled (Iloprost, BAYQ6256)
- Keywords
- Pulmonary hypertension, Inhaled iloprost, Efficacy, Safety, Tolerability, Survival, NYHA class III and IV
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventavis inhaled (Iloprost, BAYQ6256)Drug
Since this study is an observational, inhaled iloprost dosage and frequency for each patient will be prescribed by physicians as medically required.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Ventavis inhaled (Iloprost, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes walking distance (change in meters)
Measured: At month 48
Adverse events, weight, vital findings
Measured: At month 48
Secondary outcomes (5)
6 Minutes walking distance (% change)
Measured: At month 48
New York Heart Association Functional Class
Measured: At month 48
Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change
Measured: At month 48
Pulmonary hypertension related hospitalization
Measured: At month 48
Heart and/or lung transplantation, mortality
Measured: At month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study start3 Feb 2011
- Primary completion8 Mar 2017
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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
- 118 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
- NCT01389271
- Sponsor's protocol ID
- 14990
- Other IDs
- VE0910TR
- Acronym
- OPTION
- Status last verified
- Apr 2019
- First submitted
- 27 Jun 2011
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
- ClinicalTrials.gov ID
- NCT01389271
- Acronym / sponsor ID
- OPTION / 14990
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension, Inhaled iloprost, Efficacy, Safety, Tolerability, Survival, NYHA class III and IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2011 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 8 Jul 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 an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Ventavis inhaled (Iloprost, BAYQ6256) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary (idiopathic and familial) pulmonary hypertension and PAH secondary to scleroderma without significant interstitial pulmonary disease classified as New York Heart Association (NYHA) functional class III and IV
Key inclusion criteria (4 listed)
- Patients who has pulmonary hypertension treated with inhaled iloprost older than 18 years old.
- Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
- Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
- Patients who signed written informed consent.
Key exclusion criteria (7 listed)
- Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision;
- Severe arrhythmias;
- Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
- Pulmonary hypertension due to venous occlusive disease.
- Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
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 inhaled (Iloprost, BAYQ6256)Since this study is an observational, inhaled iloprost dosage and frequency for each patient will be prescribed by physicians as medically required. | Drug | Group 1 |
Primary outcome
6 Minutes walking distance (change in meters)
Time frame: At month 48
Adverse events, weight, vital findings
Time frame: At month 48
5 secondary outcomes
6 Minutes walking distance (% change)
Time frame: At month 48
New York Heart Association Functional Class
Time frame: At month 48
Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change
Time frame: At month 48
Pulmonary hypertension related hospitalization
Time frame: At month 48
Heart and/or lung transplantation, mortality
Time frame: At month 48
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 25 Apr 2019.
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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 Hypertension, run by Bayer at 1 site in Turkey (Türkiye).
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 7 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 25 Apr 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 Turkey (Türkiye). 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?
6 Minutes walking distance (change in meters) (time frame: At month 48). 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?
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 25 Apr 2019.