Pulmonary Arterial HypertensionPhase 4NCT00705588
Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
A Phase 4 study testing Tadalafil and Vardenafil in people with Pulmonary Arterial Hypertension, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Tadalafil and Vardenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Jan 2010
- 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 years and older
- 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 or >30mmHg with exercise, by a PCWP< 15mmHg and by PVR >3 Wood Units.
- Currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
- 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 congenital heart disease are eligible for inclusion.
Who cannot join
- Functional Class NYHA Class I.
- PAH due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (VC or FEV1 < 60% of predicted) or chronic hypoxia.
- 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.
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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
Benjamin D Fox, BM BCh MRCP
About this study
Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil).
Although these drugs are known to be effective alone, little is known about combining them together in various combinations.
In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Tadalafil, Vardenafil
- 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.
TadalafilDrug
Also called Cialis
Orally, titrated to maximum 20mg od
VardenafilDrug
Also called Levitra
Orally, titrated to 10 mg bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis). Receives: Drug: Tadalafil |
| 2 | Experimental | Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra) Receives: Drug: Vardenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walking distance
Measured: 12 weeks
Level of pro-NT BNP
Measured: 12 weeks
Secondary outcomes (2)
Echo-derived parameters
Measured: 12 weeks
Cardiopulmonary exercise test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2010 (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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Mordechai R Kramer, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705588
- Sponsor's protocol ID
- RMC084936CTIL
- Status last verified
- May 2008
- First submitted
- 25 Jun 2008
- Last updated
- 26 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
- ClinicalTrials.gov ID
- NCT00705588
- Acronym / sponsor ID
- RMC084936CTIL
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jan 2010 (estimated)
- First posted
- 26 Jun 2008 (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.
Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil).
Although these drugs are known to be effective alone, little is known about combining them together in various combinations.
In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TadalafilPatients treated with epoprostenol (Flolan) will be given tadalafil (Cialis). |
| 2 | Experimental | Drug: VardenafilPatients receiving iloprost (Ventavis) will receive vardenafil (Levitra) |
Who may qualify
- Ages
- 18 years and older
- 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 or >30mmHg with exercise, by a PCWP< 15mmHg and by PVR >3 Wood Units.
- Currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
- 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 chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (VC or FEV1 < 60% of predicted) or chronic hypoxia.
- 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 |
|---|---|---|
| TadalafilAlso: CialisOrally, titrated to maximum 20mg od | Drug | 1 |
| VardenafilAlso: LevitraOrally, titrated to 10 mg bid | Drug | 2 |
Primary outcome
Six minute walking distance
Time frame: 12 weeks
Level of pro-NT BNP
Time frame: 12 weeks
2 secondary outcomes
Echo-derived parameters
Time frame: 12 weeks
Cardiopulmonary exercise test
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2008.
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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.
Mordechai R Kramer, MD principal investigator
Rabin Medical Center
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 Tadalafil and Vardenafil 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 26 Jun 2008. 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 (972-3-937-7221, kremerm@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walking distance (time frame: 12 weeks). The study lists 2 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 26 Jun 2008.