Primary HypertensionNCT00882947
Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)
An observational study of Primary Hypertension, run by Bayer at 1 site in China.
Trial summary
The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Ventavis (Iloprost, BAYQ6256)
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- Feb 2006to Sep 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Chinese patients (age 18-65 male and female) with Primary Pulmonary Hypertension
Who may be able to join
- Both male and female age 18-65 years old
- The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
- Patient with Primary Pulmonary Hypertension (i.e. IPAH or FPAH) and classified as NYHA functional class III
- Written informed/data protection consent
- No prior treatment with Ventavis or other active treatments for PPH within 6 weeks of date of study.
Who cannot join
- Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation.
- Conditions
- Primary Hypertension
- Being tested
- Ventavis (Iloprost, BAYQ6256)
- Keywords
- Primary Pulmonary Hypertension (PPH)
- Medical subject headings
- Essential Hypertension, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventavis (Iloprost, BAYQ6256)Drug
Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Ventavis (Iloprost, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Measured: At week 4,12 and 24
Secondary outcomes (2)
6 minute walking test (6-MWT)
Measured: At week 4,12 and 24
NYHA functional class
Measured: At week 4,12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startFeb 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- 38 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
- NCT00882947
- Sponsor's protocol ID
- 14183
- Other IDs
- VE0611CN
- Status last verified
- Apr 2009
- First submitted
- 16 Apr 2009
- Last updated
- 17 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)
- ClinicalTrials.gov ID
- NCT00882947
- Acronym / sponsor ID
- 14183
- Conditions
- Primary Hypertension
- Keywords
- Primary Pulmonary Hypertension (PPH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Apr 2009 (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 demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Ventavis (Iloprost, BAYQ6256) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Chinese patients (age 18-65 male and female) with Primary Pulmonary Hypertension
Key inclusion criteria (5 listed)
- Both male and female age 18-65 years old
- The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
- Patient with Primary Pulmonary Hypertension (i.e. IPAH or FPAH) and classified as NYHA functional class III
- Written informed/data protection consent
- No prior treatment with Ventavis or other active treatments for PPH within 6 weeks of date of study.
Key exclusion criteria (1 listed)
- Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product 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 |
|---|---|---|
| Ventavis (Iloprost, BAYQ6256)Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog | Drug | Group 1 |
Primary outcome
Frequency of Adverse Events
Time frame: At week 4,12 and 24
2 secondary outcomes
6 minute walking test (6-MWT)
Time frame: At week 4,12 and 24
NYHA functional class
Time frame: At week 4,12 and 24
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 Apr 2009.
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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 Primary Hypertension, run by Bayer at 1 site in China.
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 5 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 Apr 2009. 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 China. 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?
Frequency of Adverse Events (time frame: At week 4,12 and 24). 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 Apr 2009.