Primary and Secondary Pulmonary HypertensionNCT00155714
Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension
A study testing type-5 phosphodiesterase Inhibitor (Sildenafil) in people with Primary and Secondary Pulmonary Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Primary and Secondary Pulmonary Hypertension
- What is being tested?
- type-5 phosphodiesterase Inhibitor (Sildenafil)
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2002to May 2005
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria:Patients with primary and secondary pulmonary arterial hypertension
-
Exclusion Criteria:Unstable patients or patients with allergy to sildenafil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Type-5 Phosphodiesterase Inhibitors (Sildenafil and Vadenafil) in Primary and Secondary Pulmonary Hypertension
The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension
Read the detailed description
Patients with primary and secondary pulmonary hypertension will be recruited and admitted to the ICUs of the National Taiwan University Hospital. Each patient will undergo Swan-Ganz catheterization and hemodynamic monitoring during administration of sildenafil. Efficacy of inhaled NO and Iloprost will also be compared.
- Being tested
- type-5 phosphodiesterase Inhibitor (Sildenafil)
- Keywords
- pulmonary arterial hypertension, type-5 phosphodiesterase Inhibitors, Sildenafil
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type-5 phosphodiesterase Inhibitor (Sildenafil)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pulmonary artery pressure
6 min walking distance
WHO functional status
PaO2
Secondary outcomes (2)
cardiac output
VO2max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2002
- Study completionMay 2005 (estimated)
Why it stopped: We can't obtained the test drug (Vadenafil) from Bayer. They decided not to carry out this trail in Taiwan. Therefore this trail has never been started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary and Secondary Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ping-Hung Kuo, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155714
- Sponsor's protocol ID
- 9100017321
- Status last verified
- Jan 2010
- First submitted
- 9 Sep 2005
- Last updated
- 16 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Type-5 Phosphodiesterase Inhibitors (Sildenafil and Vadenafil) in Primary and Secondary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00155714
- Acronym / sponsor ID
- 9100017321
- Keywords
- pulmonary arterial hypertension, type-5 phosphodiesterase Inhibitors, Sildenafil
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We can't obtained the test drug (Vadenafil) from Bayer. They decided not to carry out this trail in Taiwan. Therefore this trail has never been started.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- May 2005 (estimated)
- First posted
- 12 Sep 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.
The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension
Detailed description
Patients with primary and secondary pulmonary hypertension will be recruited and admitted to the ICUs of the National Taiwan University Hospital. Each patient will undergo Swan-Ganz catheterization and hemodynamic monitoring during administration of sildenafil. Efficacy of inhaled NO and Iloprost will also be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| type-5 phosphodiesterase Inhibitor (Sildenafil) | Drug | – |
Primary outcome
mean pulmonary artery pressure
6 min walking distance
WHO functional status
PaO2
2 secondary outcomes
cardiac output
VO2max
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
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.
Ping-Hung Kuo, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing type-5 phosphodiesterase Inhibitor (Sildenafil) in people with Primary and Secondary Pulmonary Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 16 Mar 2010. 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 Taiwan. 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 was withdrawn before enrolling participants, so there are no results.
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?
mean pulmonary artery pressure. The study lists 4 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 16 Mar 2010; AzTrials last refreshed its copy on 8 Nov 2026.