Pulmonary HypertensionNCT01062282
Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)
An observational study of Pulmonary Hypertension, run by Bayer at 1 site in South Korea.
Trial summary
The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method. 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?
- Iloprost (Ventavis BAYQ6256)
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2006to Jun 2009
- 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 pulmonary hypertension in Korea
Who may be able to join
- The treating physician has chosen Ventavis as a suitable treatment for the patient
- Patient with PH and classified as NYHA functional class III or IV and WHO group 1
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 patient package insert).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension
The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.
- Conditions
- Pulmonary Hypertension
- Being tested
- Iloprost (Ventavis BAYQ6256)
- Keywords
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost (Ventavis BAYQ6256)Drug
Patients with pulmonary arterial hypertension, classified as New York Heart Association functional class III or IV where the treating physician has chosen Ventavis as a suitable treatment prior to inclusion into this non-interventional study. Patients should not have received prior treatment with Ventavis
| 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
Measured: At baseline and month 1,3,6 for an observational period of 6 months
Secondary outcomes (4)
New York Heart Association functional class
Measured: Baseline, month 1,3,6
PH-related symptoms and change of concomitant medication
Measured: Baseline, month 1,3,6
Hemodynamic parameters
Measured: If applicable ( at any time during Ventavis treatment)
Adverse Event collection
Measured: If applicable (during the study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJul 2006
- Primary completionJun 2009
- Study completionJun 2009
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
- Time perspective
- Prospective
- Enrolment
- 41 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
- NCT01062282
- Sponsor's protocol ID
- 14184
- Other IDs
- VENIS, VE0610KR
- Status last verified
- Apr 2011
- First submitted
- 20 Aug 2009
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01062282
- Acronym / sponsor ID
- 14184
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Feb 2010 (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 gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.
Study design
- 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 pulmonary hypertension in Korea
Key inclusion criteria (2 listed)
- The treating physician has chosen Ventavis as a suitable treatment for the patient
- Patient with PH and classified as NYHA functional class III or IV and WHO group 1
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 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)Patients with pulmonary arterial hypertension, classified as New York Heart Association functional class III or IV where the treating physician has chosen Ventavis as a suitable treatment prior to inclusion into this non-interventional study. Patients should not have received prior treatment with Ventavis | Drug | Group 1 |
Primary outcome
The primary efficacy variable is 6-minute walking distance
Time frame: At baseline and month 1,3,6 for an observational period of 6 months
4 secondary outcomes
New York Heart Association functional class
Time frame: Baseline, month 1,3,6
PH-related symptoms and change of concomitant medication
Time frame: Baseline, month 1,3,6
Hemodynamic parameters
Time frame: If applicable ( at any time during Ventavis treatment)
Adverse Event collection
Time frame: If applicable (during the study period)
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 4 Apr 2011.
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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 South Korea.
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 2 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 4 Apr 2011. 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 South Korea. 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 (time frame: At baseline and month 1,3,6 for an observational period of 6 months). 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 4 Apr 2011.