COPDPhase 2NCT00677872
An Open-Label Study to Evaluate the Safety and Efficacy of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
A Phase 2 study testing PRX-08066 in people with COPD and Pulmonary Hypertension, run by Epix Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
A 3-month open label study to evaluate the safety and efficacy of PRX-08066 in patients with pulmonary hypertension and COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Pulmonary Hypertension
- What is being tested?
- PRX-08066
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2008
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women >40 years of age
- Diagnosis of COPD with an FEV1 above 20% and less than 65% of predicted normal and an FEV1-to-FVC ratio of less than 70%
- Diagnosis of pulmonary hypertension based on echocardiography within the last 6 months or by cardiac catheterization within the last 12 months
- New York Heart Association(NYHA)Class II or III
- Screening LVEF>55%, obtained by any appropriate method within 6 months of screening
- Baseline 6MWT distance>150m and <450m
- Written informed consent from each subject prior to the initiation of any study-related procedure
- Documented negative results (within 12 months)and Hepatitis B and Hepatitis C Serology
Who cannot join
- Treatment for pulmonary hypertension with epoprostenol (prostacyclin), trepostinil (Remodulin), iloprost (Ventavis), bosentan (Tracleer), ambrisentan (Letairis), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) within the 30 days prior to study entry
- Presence or history of any of the following cardiovascular co-morbidities or conditions: Un-controlled systemic hypertension at screening; unstable cardiovascular disease including intermittent atrial fibrillation or unstable angina within the 4 weeks prior to screening; amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis; history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous cardiac intervention within the 3 months prior to screening; significant valvular heart disease; cerebrovascular accident or transient ischemic attack within 3 months prior to screening
- COPD exacerbation less than 1 month prior to screening
- Exercise tolerance limited by non-cardiac causes
- Clinically significant psychiatric, addictive, neurologic disease or condition
- Chronic renal impairment or renal insufficiency
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- No clinically significant laboratory abnormalities
- Subjects currently being treated for PH with prostnoids, PDE-5 inhibitors and or endothelin receptor antagonist. The use of PDE-5 inhibitors "as needed" for erectile dysfunction is acceptable as long as the subject does not take the medication within 72 hours of an efficacy assessment. Other concomitant medications are allowed provided the subject has been on a stable dose regimen for at least 4 weeks prior to enrollment and the regimen continues and remains stable during the treatment and follow-up periods.
- History of nasal airway mass, septal perforation, chronic sinusitis, lidocaine allergy or current nasal passage condition that would decrease the safety or tolerability of a naso-esophageal catheter
- The subject has the presence, or history, of malignancy that required significant medical intervention within the preceding 3 months and/or is likely to result in death within the next 2 years
- The receipt of any investigational medication within 30 days prior to screening or anytime during the course of the study
- Women cannot be pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Pulmonary and Critical Care Unit
Boston, Massachusetts, 02114
About this study
A 3-month open label study to evaluate the safety and efficacy of PRX-08066 in patients with pulmonary hypertension and COPD.
- Conditions
- COPD, Pulmonary Hypertension
- Being tested
- PRX-08066
- Keywords
- Moderate to severe COPD and coincident pulmonary hypertension
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-08066Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PRX-08066 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test (6-MWT)and mean pulmonary artery pressure (MPAP) utilizing right heart catheterization.
Secondary outcomes (1)
Central hemodynamic and exercise capacity parameters utilizing RHC and CPET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677872
- Sponsor's protocol ID
- PRX-08066-202
- Status last verified
- Jul 2009
- First submitted
- 13 May 2008
- Last updated
- 30 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety and Efficacy of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00677872
- Acronym / sponsor ID
- PRX-08066-202
- Conditions
- COPD, Pulmonary Hypertension
- Keywords
- Moderate to severe COPD and coincident pulmonary hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Epix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2008 (estimated)
- First posted
- 15 May 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.
A 3-month open label study to evaluate the safety and efficacy of PRX-08066 in patients with pulmonary hypertension and COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PRX-08066 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and Women >40 years of age
- Diagnosis of COPD with an FEV1 above 20% and less than 65% of predicted normal and an FEV1-to-FVC ratio of less than 70%
- Diagnosis of pulmonary hypertension based on echocardiography within the last 6 months or by cardiac catheterization within the last 12 months
- New York Heart Association(NYHA)Class II or III
- Screening LVEF>55%, obtained by any appropriate method within 6 months of screening
Key exclusion criteria (12 listed)
- Treatment for pulmonary hypertension with epoprostenol (prostacyclin), trepostinil (Remodulin), iloprost (Ventavis), bosentan (Tracleer), ambrisentan (Letairis), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) within the 30 days prior to study entry
- Presence or history of any of the following cardiovascular co-morbidities or conditions: Un-controlled systemic hypertension at screening; unstable cardiovascular disease including intermittent atrial fibrillation or unstable angina within the 4 weeks prior to screening; amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis; history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous cardiac intervention within the 3 months prior to screening; significant valvular heart disease; cerebrovascular accident or transient ischemic attack within 3 months prior to screening
- COPD exacerbation less than 1 month prior to screening
- Exercise tolerance limited by non-cardiac causes
- Clinically significant psychiatric, addictive, neurologic disease or condition
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 |
|---|---|---|
| PRX-08066 | Drug | 1 |
Primary outcome
Six-minute walk test (6-MWT)and mean pulmonary artery pressure (MPAP) utilizing right heart catheterization.
1 secondary outcome
Central hemodynamic and exercise capacity parameters utilizing RHC and CPET
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRX-08066 in people with COPD and Pulmonary Hypertension, run by Epix Pharmaceuticals, Inc. at 1 site in United States.
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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 30 Jul 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Six-minute walk test (6-MWT)and mean pulmonary artery pressure (MPAP) utilizing right heart catheterization.. 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 30 Jul 2009.