Pulmonary HypertensionPhase 2NCT00345774
Safety and Effectiveness of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
A Phase 2 study testing PRX-08066 in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by Epix Pharmaceuticals, Inc. at 19 sites in United States.
Trial summary
This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 25 to 79 years
- Conditions the study is for
- Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
- What is being tested?
- PRX-08066
- How many people
- 72 participants
- Where
- 19 sitesUnited States
- Study dates
- Jun 2006to Jun 2007
- 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 25 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 to 79 years old.
- Provide voluntary written informed consent to participate.
- Smoking history of at least 10 pack years (1 pack of cigarettes per day for 10 years).
- Diagnosis of chronic obstructive pulmonary disease.
- Become short of breath with physical activity.
- Elevated systolic pulmonary artery pressures.
- Not pregnant, nursing, or planning a pregnancy.
Who cannot join
- Left ventricular ejection fraction <30%.
- Heart attack or stroke within the last 6 months.
- History of lung resection surgery.
- Use of supplemental oxygen >20 hours/day.
- Blood donation or significant blood loss within the last 56 days.
- Plasma donation within the last 14 days.
Show all 11Show fewer
- Use of any drugs for another research study within the last 30 days.
- Use of vasodilators, long acting nitrates, prostacyclin analogs, endothelin antagonists, or phosphodiesterase inhibitor drugs within the last 14 days.
- Positive blood screen Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody.
- Major surgery within the last 28 days.
- Any other medical condition that may jeopardize the safety of the subject, the validity of the study results, or interfere with the completion of the study according to the protocol.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Tufts New England Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital, Pulmonary Critical Care Unit
Boston, Massachusetts, 02114
American Health Research
Charlotte, North Carolina, 28207
Pulmonary Consultants of North Idaho
Coeur d'Alene, Idaho, 83814
Atlanta Insitute for Medical Research
Decatur, Georgia, 30030
University Clinical Research-DeLand, LLC
DeLand, Florida, 32720
Baylor College of Medicine
Houston, Texas, 77030
Loyola University Medical Center Foster McGraw Hospital
Maywood, Illinois, 60153
Heart Care Associates, LLC
Milwaukee, Wisconsin, 53215
Morgantown Pulmonary Clinical Research
Morgantown, West Virginia, 26505
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, 85013
University of California-Davis Medical Group
Sacramento, California, 95817
South Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Central Medical Group, PA
Tamarac, Florida, 33321
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Veritas Clinical Specialities
Topeka, Kansas, 66606
Buffalo Cardiology and Pulmonary Associates, P.C.
Williamsville, New York, 14221
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Short-Term Efficacy and Safety of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.
- Being tested
- PRX-08066
- Keywords
- Pulmonary Hypertension, PH, Pulmonary Arterial Hypertension, PAH, Chronic Obstructive Pulmonary Disease, COPD, PRX-08066, Predix
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-08066Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Pulmonary Artery Pressure
Secondary outcomes (8)
Safety
6 minute walk distance
Borg Dyspnea Index
BDI/TDI
Echocardiograms
Spirometry
Oxygen saturation
WHO functional classification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startJun 2006
- Study completionJun 2007
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345774
- Sponsor's protocol ID
- PRX-CP-017
- Status last verified
- May 2008
- First submitted
- 27 Jun 2006
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Short-Term Efficacy and Safety of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00345774
- Acronym / sponsor ID
- PRX-CP-017
- Keywords
- Pulmonary Hypertension, PH, Pulmonary Arterial Hypertension, PAH, Chronic Obstructive Pulmonary Disease, COPD, PRX-08066, Predix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Epix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 28 Jun 2006 (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.
This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 25 to 79 years old.
- Provide voluntary written informed consent to participate.
- Smoking history of at least 10 pack years (1 pack of cigarettes per day for 10 years).
- Diagnosis of chronic obstructive pulmonary disease.
- Become short of breath with physical activity.
Key exclusion criteria (11 listed)
- Left ventricular ejection fraction <30%.
- Heart attack or stroke within the last 6 months.
- History of lung resection surgery.
- Use of supplemental oxygen >20 hours/day.
- Blood donation or significant blood loss within the last 56 days.
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 | – |
Primary outcome
Systolic Pulmonary Artery Pressure
8 secondary outcomes
Safety
6 minute walk distance
Borg Dyspnea Index
BDI/TDI
Echocardiograms
Spirometry
Oxygen saturation
WHO functional classification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
19 sites 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 Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by Epix Pharmaceuticals, Inc. at 19 sites 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Systolic Pulmonary Artery Pressure. 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 29 May 2008.