Pulmonary Arterial HypertensionPhase 2NCT00792571
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
A Phase 2 study testing Beraprost Sodium Modified Release in people with Pulmonary Arterial Hypertension, run by Lung Biotechnology PBC at 6 sites in 3 countries.
Trial summary
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Beraprost Sodium Modified Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 28 Feb 2009to 30 Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS-MR-PAH-201 are eligible for this study.
- Female patients must either be physiologically incapable of childbearing or be practicing an acceptable method of birth control (e.g. approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or an intrauterine device).
Who cannot join
- Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) for any reason (e.g. treatment related adverse events) are not eligible for entry into this study.
- Patients who are pregnant or lactating are excluded from participation in the open-label extension.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States3 sites
UTSW Medical Center Dallas
Dallas, Texas, 75390-8550
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Harbor-UCLA Medical Center
Torrance, California, 90502
Belgium2 sites
Universite Libre de Bruxelles
Brussels
Gastuisberg University Hospital
Leuven
About this study
Official title: An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.
Read the detailed description
This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment.
Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study. Patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in BPS-MR-PAH-202 main study.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Beraprost Sodium Modified Release
- 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.
Beraprost Sodium Modified ReleaseDrug
Also called BPS-MR Tablets, 60 mcg, Beraprost Sodium Modified Release Tablet, 60 mcg
| Study group | Role | What they receive |
|---|---|---|
| B.I.D | Experimental | Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing) Receives: Drug: Beraprost Sodium Modified Release |
| Q.I.D | Experimental | Beraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing) Receives: Drug: Beraprost Sodium Modified Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
A treatment-emergent adverse event (TEAEs) is defined as an event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. AEs occurring more than 3 days after the last day study drug is taken in the study will not be included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only treatment-emergent adverse events occurring during the treatment period of the BPS-MR-PAH-202 study will be summarized. Any adverse event starting prior to the first dose of study drug will be excluded from the summary analyses and only presented in the data listings. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Up to 56 months
Number of Treatment Emergent Adverse Events Reported During The Study
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for participants with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-202 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Up to 56 months
Secondary outcomes (4)
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at End of Study
The area used for the Six Minute Walk Test (6MWT) was pre-measured at a minimum of 30 meters in length and at least 2 to 3 meters in width. There were no turns or significant curves to the 6-minute walk area. The length was marked with gradations to ensure the accurate measurement of the distance walked. The area was well ventilated with air temperature controlled at 20 to 23°C. Intermittent rest periods were allowed if the participant could no longer continue. If the participant needed to rest briefly, he/she could stand or sit and then begin again when rested but the clock continued to run. At the end of 6 minutes, the tester called "stop" while simultaneously stopping the watch and then measured the distance walked. For the purposes of the 6MWT if a participant was assessed at Baseline using oxygen therapy, then all future 6MWT were conducted in the same manner. All efficacy results are descriptive; no statistical analysis was conducted.
Measured: Baseline and 56 months
Change From Baseline in Borg Dyspnea Score at End of Study
The modified 0-10 category-ratio Borg scale consists of an 11-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) and 10 (for the worst condition) with nonlinear spacing of verbal descriptors of severity corresponding to specific numbers. The participant chose the number or the verbal descriptor to reflect presumed ratio properties of sensation or symptom intensity. Baseline was defined as the last non-missing evaluation preceding the first dose of study drug in study BPS-MR-PAH-201. Only participants with both a measurement at baseline and at the given visit are presented. All efficacy results are descriptive; no statistical analysis was conducted.
Measured: Baseline and 56 months
Number of Participants That Experienced Clinical Worsening During the Study
Number of Participants that experienced Clinical Worsening in the opinion of the Investigator. Clinical Worsening was defined as any of these events following the Baseline visit: Death, Transplantation or atrial septostomy, Clinical deterioration as defined by: Hospitalization as a result of PAH symptoms or Initiation of any new PAH specific therapy (e.g. ERA, PDE-5 inhibitor, prostanoid). All efficacy results are descriptive; no statistical analysis was conducted.
Measured: Up to 56 months
Number of Participants With a Change in WHO Functional Class
Change from Baseline in participant clinical status was recorded according to the World Health Organization (WHO) Functional Class. A change from lower to higher functional class (i.e. 'III to IV' or 'II to III') was considered as a deterioration. A change from higher to lower functional class (i.e. 'III to II' or 'II to I') was considered as an improvement. All efficacy results are descriptive; no statistical analysis was conducted.
Measured: Baseline and 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study start28 Feb 2009
- Primary completion30 Nov 2013
- Study completion30 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lung Biotechnology PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aimee Smart, Study director, Study Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792571
- Sponsor's protocol ID
- BPS-MR-PAH-202
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2008
- Last updated
- 26 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.
- ClinicalTrials.gov ID
- NCT00792571
- Acronym / sponsor ID
- BPS-MR-PAH-202
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lung Biotechnology PBCIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2009 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.
Detailed description
This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment.
Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study. Patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in BPS-MR-PAH-202 main study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B.I.D | Experimental | Drug: Beraprost Sodium Modified ReleaseBeraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing) |
| Q.I.D | Experimental | Drug: Beraprost Sodium Modified ReleaseBeraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS-MR-PAH-201 are eligible for this study.
- Female patients must either be physiologically incapable of childbearing or be practicing an acceptable method of birth control (e.g. approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or an intrauterine device).
Key exclusion criteria (2 listed)
- Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) for any reason (e.g. treatment related adverse events) are not eligible for entry into this study.
- Patients who are pregnant or lactating are excluded from participation in the open-label extension.
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 |
|---|---|---|
| Beraprost Sodium Modified ReleaseAlso: BPS-MR Tablets, 60 mcg, Beraprost Sodium Modified Release Tablet, 60 mcg | Drug | B.I.D, Q.I.D |
Primary outcome
Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to 56 months
A treatment-emergent adverse event (TEAEs) is defined as an event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. AEs occurring more than 3 days after the last day study drug is taken in the study will not be included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only treatment-emergent adverse events occurring during the treatment period of the BPS-MR-PAH-202 study will be summarized. Any adverse event starting prior to the first dose of study drug will be excluded from the summary analyses and only presented in the data listings. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Number of Treatment Emergent Adverse Events Reported During The Study
Time frame: Up to 56 months
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for participants with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-202 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
4 secondary outcomes
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at End of Study
Time frame: Baseline and 56 months
Change From Baseline in Borg Dyspnea Score at End of Study
Time frame: Baseline and 56 months
Number of Participants That Experienced Clinical Worsening During the Study
Time frame: Up to 56 months
Number of Participants With a Change in WHO Functional Class
Time frame: Baseline and 56 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Aimee Smart study director
Study Sponsor
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beraprost Sodium Modified Release in people with Pulmonary Arterial Hypertension, run by Lung Biotechnology PBC at 6 sites in 3 countries.
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 2 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 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Belgium, Ireland. 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?
Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: Up to 56 months). 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 Dec 2019.