Pulmonary HypertensionPhase 3NCT01091012
Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension
A Phase 3 study testing Sildenafil 20mg oral vs Sildenafil 10mg intravenous in people with Pulmonary Hypertension, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically… 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?
- Sildenafil 20mg oral vs Sildenafil 10mg intravenous
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Feb 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Patients clinically stable, at least 1 year after the completion of successful valve surgery, with persistent pulmonary artery systolic pressure> 50 mmHg,
- normal left ventricular function and no significant valvular disease in 2 separate Doppler ultrasound studies at least 1 month.
Who cannot join
- Patients with other cardiac and noncardiac diseases will be excluded.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vall Hebron Hospital
Barcelona, Barcelona, 08035
Enric Domingo, Physician, 00-34-93-2746455, edrcg@hotmail.com
Enric Domingo, Physician
About this study
Official title: Study About Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension, at Last Moderate and Secondary at Valve Disease(Corrected With a Normally Functioning Prosthesis).
The main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically significant.
- Conditions
- Pulmonary Hypertension
- Being tested
- Sildenafil 20mg oral vs Sildenafil 10mg intravenous
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 20mg oral vs Sildenafil 10mg intravenousDrug
Also called REVATIO oral vs REVATIO intravenous
2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil 20mg oral | Other | Not described Receives: Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous |
| Sildenafil 10mg intravenous | Other | Not described Receives: Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance.
Measured: one day per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
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 Hospital Universitari Vall d'Hebron Research InstituteThe 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enric Domingo, Promotor, Principal investigator, Vall Hebron Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091012
- Sponsor's protocol ID
- DOM-SIL-2009
- Other IDs
- 2009-012005-19, 2009
- Status last verified
- Sep 2012
- First submitted
- 2 Mar 2010
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study About Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension, at Last Moderate and Secondary at Valve Disease(Corrected With a Normally Functioning Prosthesis).
- ClinicalTrials.gov ID
- NCT01091012
- Acronym / sponsor ID
- DOM-SIL-2009
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 23 Mar 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 main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically significant.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil 20mg oral | Other | Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous |
| Sildenafil 10mg intravenous | Other | Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients clinically stable, at least 1 year after the completion of successful valve surgery, with persistent pulmonary artery systolic pressure> 50 mmHg,
- normal left ventricular function and no significant valvular disease in 2 separate Doppler ultrasound studies at least 1 month.
Key exclusion criteria (1 listed)
- Patients with other cardiac and noncardiac diseases will be excluded.
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 |
|---|---|---|
| Sildenafil 20mg oral vs Sildenafil 10mg intravenousAlso: REVATIO oral vs REVATIO intravenous2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg | Drug | Sildenafil 10mg intravenous, Sildenafil 20mg oral |
Primary outcome
Effectiveness
Time frame: one day per patient
The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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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.
Enric Domingo, Promotor principal investigator
Vall Hebron Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil 20mg oral vs Sildenafil 10mg intravenous in people with Pulmonary Hypertension, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 11 Sep 2012. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enric Domingo, Promotor (00-34-93-2746455, edrcg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: one day per patient). 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 11 Sep 2012.