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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00792571 |
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Date of registration:
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14/11/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
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Scientific title:
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An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients. |
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Date of first enrolment:
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February 28, 2009 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00792571 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Ireland
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United States
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Contacts
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Name:
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Aimee Smart |
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Address:
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Telephone:
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Email:
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Affiliation:
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Study Sponsor |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Beraprost Sodium Modified Release
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Primary Outcome(s)
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Number of Treatment Emergent Adverse Events Reported During The Study
[Time Frame: Up to 56 months]
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Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
[Time Frame: Up to 56 months]
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Secondary Outcome(s)
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Change From Baseline in Borg Dyspnea Score at End of Study
[Time Frame: Baseline and 56 months]
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Number of Participants With a Change in WHO Functional Class
[Time Frame: Baseline and 56 months]
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Number of Participants That Experienced Clinical Worsening During the Study
[Time Frame: Up to 56 months]
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Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at End of Study
[Time Frame: Baseline and 56 months]
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Secondary ID(s)
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BPS-MR-PAH-202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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