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An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
This study has been completed.
Sponsor:
Lung Biotechnology PBC
Information provided by (Responsible Party):
Lung Biotechnology PBC
ClinicalTrials.gov Identifier:
NCT00792571
First received: November 14, 2008
Last updated: May 19, 2014
Last verified: May 2014
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Purpose
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.
| Condition | Intervention | Phase |
|---|---|---|
| Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients. |
Resource links provided by NLM:
Further study details as provided by Lung Biotechnology PBC:
Primary Outcome Measures:
- 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. ]
Secondary Outcome Measures:
- 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. ]
| Enrollment: | 18 |
| Study Start Date: | February 2009 |
| Study Completion Date: | November 2013 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: B.I.D
Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)
|
Drug: Beraprost Sodium Modified Release
Other Names:
|
|
Experimental: Q.I.D
Beraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing)
|
Drug: Beraprost Sodium Modified Release
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792571
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792571
Locations
| 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 | |
Sponsors and Collaborators
Lung Biotechnology PBC
Investigators
| Study Director: | Aimee Smart | Study Sponsor |
More Information
| Responsible Party: | Lung Biotechnology PBC |
| ClinicalTrials.gov Identifier: | NCT00792571 History of Changes |
| Other Study ID Numbers: |
BPS-MR-PAH-202 |
| Study First Received: | November 14, 2008 |
| Last Updated: | May 19, 2014 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on August 16, 2017