An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
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| ClinicalTrials.gov Identifier: NCT00792571 |
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Recruitment Status :
Completed
First Posted : November 18, 2008
Last Update Posted : May 29, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 18 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients. |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | November 2013 |
| Actual Study Completion Date : | November 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: B.I.D
Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)
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Drug: Beraprost Sodium Modified Release
Other Names:
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Experimental: Q.I.D
Beraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing)
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Drug: Beraprost Sodium Modified Release
Other Names:
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- The primary outcome is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in BPS-MR-PAH-201 study [ Time Frame: In order to evaluate the long-term safety and efficacy of BPS-MR, the study is expected to continue until the first of either of the following is reached: December 31, 2014 or LungRx discontinues the project. ]
- The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test, the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS-MR-PAH-201 study. [ Time Frame: In order to evaluate the long-term safety and efficacy of BPS-MR, the study is expected to continue until the first of either of the following is reached: December 31, 2014 or LungRx discontinues the project. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792571
| United States, California | |
| Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90502 | |
| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Texas | |
| UTSW Medical Center Dallas | |
| Dallas, Texas, United States, 75390-8550 | |
| Belgium | |
| Universite Libre de Bruxelles | |
| Bruxelles, Belgium | |
| Gastuisberg University Hospital | |
| Leuven, Belgium | |
| Ireland | |
| Mater Misericordiae University Hospital Ltd. | |
| Dublin, Ireland | |
| Study Director: | Aimee Smart | Study Sponsor |
| Responsible Party: | Lung Biotechnology PBC |
| ClinicalTrials.gov Identifier: | NCT00792571 History of Changes |
| Other Study ID Numbers: |
BPS-MR-PAH-202 |
| First Posted: | November 18, 2008 Key Record Dates |
| Last Update Posted: | May 29, 2014 |
| Last Verified: | May 2014 |
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases |
Respiratory Tract Diseases Beraprost Epoprostenol Platelet Aggregation Inhibitors Vasodilator Agents Antihypertensive Agents |