Pulmonary Arterial HypertensionPhase 4NCT01649739
Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
A Phase 4 study testing Levitra in people with Pulmonary Arterial Hypertension, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Patients with pulmonary arterial hypertension (PAH) suffer from breathlessness, poor quality of life and inability to function, despite medical therapy Current consensus states that combination therapy with different classes of PAH-specific therapy is likely to bring additional benefit to PAH patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Levitra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Jan 2014
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): Mean PAP≥25mmHg at rest by a PCWP<15mmHg and by PVR >3 Wood Units.
- Currently stable for at least 3 months with inhaled iloprost, between 5-9 doses per day, using the I-Neb device.
- Willing and able to participate in all study follow-up procedures.
- New York Heart Association (NYHA) Class II-IV.
- Six minute walking distance between 100-450 meters at the baseline assessment.
- Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
- Patients with inoperable pulmonary thromboembolic disease or congenital heart disease are eligible for inclusion.
Who cannot join
- Functional Class NYHA Class I.
- PAH due to left heart disease, chronic lung diseases (VC or FEV1 <60% of predicted), chronic hypoxia or chronic thromboembolic disease.
- Acute intercurrent illness requiring hospital admission in the month proceeding screening.
- Any non-PAH medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
- Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
- Concomitant therapy with drugs known to interact adversely with the study drug (Nitrates, alpha-adrenergic receptor antagonists, CYP3A4 inhibitors (HIV protease inhibitors, ketoconazole, itraconazole, erythromycin
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- Chronic renal failure - creatinine clearance< 50ml/min as calculated with the Cockcroft equation.
- Current participation in another clinical trial.
- Pregnancy or planned pregnancy during the study period.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pulmonary Institute,Rabin Medical Center
Petah Tikva, 49100
Mordechai R Kramer, MD, 972-39377221, kremerm@clalit.org.il
Mordechai R Kramer, MD
About this study
Patients with pulmonary arterial hypertension (PAH) suffer from breathlessness, poor quality of life and inability to function, despite medical therapy Current consensus states that combination therapy with different classes of PAH-specific therapy is likely to bring additional benefit to PAH patients. In this study we plan to study how exercise performance changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain symptomatic from PAH when treated with inhaled iloprost.
Following baseline assessment, all Patients will start vardenafil 10 mg bid. If the drug is tolerated by the patients, after a two week period, up titration to 20 mg bid will be permitted, at the discretion of the investigators.
Read more
According to treatment protocol up titration will be done carefully and whenever side effects will be reported up titration will be stopped or dosage will be decreased or stopped according to the investigator judgment.
Systemic BP will be measured at baseline assessment. The patient will attend the clinic for the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg.
Systemic BP will be measured at baseline assessment. The patient will attend the clinic for the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg. A fall in SBP of>30 mmHg will be considered significant or any smaller value at the discretion of the investigator. BP will be measured according to the following protocol.
Pre-dose Immediately before administration of vardenafil. This will be timed approximately one hour prior to the next planned dose of iloprost.
Pre-inhalation One hour post vardenafil dose, immediately prior to iloprost inhalation.
Post-inhalation Immediately following completion of iloprost inhalation and every fifteen minutes for one hour.
Prior to discharge Two hours following the iloprost.
Later monitoring At all follow-up visits, BP will be measured.
This is an open-label study to evaluate the safety and efficacy of adding higher doses of vardenafil to inhaled iloprost over 3 months.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Levitra
- Keywords
- PAH
- 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.
LevitraDrug
There is 2 dosage:10mg Twice daily and 20mg Twice daily
| Study group | Role | What they receive |
|---|---|---|
| Levitra | Experimental | Not described Receives: Drug: Levitra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walk or New York Heart Association functional class.
Measured: 14 weeks
Secondary outcomes (1)
Changes in Pulmonary artery pressure assessed (by echo), exercise test parameters, pro-NT BNP, quality of life. Clinical worsening during study, study drop-out and adverse events during the study.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mordechai Kremer, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649739
- Sponsor's protocol ID
- RMCVAR1234
- Status last verified
- Jul 2012
- First submitted
- 22 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
- ClinicalTrials.gov ID
- NCT01649739
- Acronym / sponsor ID
- RMCVAR1234
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 25 Jul 2012 (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.
Patients with pulmonary arterial hypertension (PAH) suffer from breathlessness, poor quality of life and inability to function, despite medical therapy Current consensus states that combination therapy with different classes of PAH-specific therapy is likely to bring additional benefit to PAH patients. In this study we plan to study how exercise performance changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain symptomatic from PAH when treated with inhaled iloprost.
Following baseline assessment, all Patients will start vardenafil 10 mg bid. If the drug is tolerated by the patients, after a two week period, up titration to 20 mg bid will be permitted, at the discretion of the investigators.
According to treatment protocol up titration will be done carefully and whenever side effects will be reported up titration will be stopped or dosage will be decreased or stopped according to the investigator judgment.
Systemic BP will be measured at baseline assessment. The patient will attend the clinic for the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg.
Systemic BP will be measured at baseline assessment. The patient will attend the clinic for the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg. A fall in SBP of>30 mmHg will be considered significant or any smaller value at the discretion of the investigator. BP will be measured according to the following protocol.
Pre-dose Immediately before administration of vardenafil. This will be timed approximately one hour prior to the next planned dose of iloprost.
Pre-inhalation One hour post vardenafil dose, immediately prior to iloprost inhalation.
Post-inhalation Immediately following completion of iloprost inhalation and every fifteen minutes for one hour.
Prior to discharge Two hours following the iloprost.
Later monitoring At all follow-up visits, BP will be measured.
This is an open-label study to evaluate the safety and efficacy of adding higher doses of vardenafil to inhaled iloprost over 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levitra | Experimental | Drug: Levitra |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All Patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): Mean PAP≥25mmHg at rest by a PCWP<15mmHg and by PVR >3 Wood Units.
- Currently stable for at least 3 months with inhaled iloprost, between 5-9 doses per day, using the I-Neb device.
- Willing and able to participate in all study follow-up procedures.
- New York Heart Association (NYHA) Class II-IV.
- Six minute walking distance between 100-450 meters at the baseline assessment.
Key exclusion criteria (9 listed)
- Functional Class NYHA Class I.
- PAH due to left heart disease, chronic lung diseases (VC or FEV1 <60% of predicted), chronic hypoxia or chronic thromboembolic disease.
- Acute intercurrent illness requiring hospital admission in the month proceeding screening.
- Any non-PAH medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
- Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
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 |
|---|---|---|
| LevitraThere is 2 dosage:10mg Twice daily and 20mg Twice daily | Drug | Levitra |
Primary outcome
Change in 6 minute walk or New York Heart Association functional class.
Time frame: 14 weeks
1 secondary outcome
Changes in Pulmonary artery pressure assessed (by echo), exercise test parameters, pro-NT BNP, quality of life. Clinical worsening during study, study drop-out and adverse events during the study.
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levitra in people with Pulmonary Arterial Hypertension, run by Rabin Medical Center at 1 site in Israel.
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 7 inclusion and 9 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 25 Jul 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mordechai R Kramer, MD (972-505710702, kremerm@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 minute walk or New York Heart Association functional class. (time frame: 14 weeks). 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 Jul 2012.