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NCT00781885 · ClinicalTrials.gov registry record · Phase 2
A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients
A Phase 2 study, sponsored by Lung Biotechnology PBC.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00781885: Completed Phase 2 study, sponsored by Lung Biotechnology PBC.
NCT00781885 is a Phase 2 study that has completed, run by Lung Biotechnology PBC. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00781885, a Phase 2 study, has completed, sponsored by Lung Biotechnology PBC.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study is an international, open-label, multi-center, Phase II, multiple dose, dose-finding study to investigate the safety, tolerability and pharmacokinetic characteristics of BPS-MR tablets in male and female patients with PAH. Patients who meet the inclusion/exclusion criteria will enter the Treatment Phase at a Baseline visit. Patients will begin taking one BPS-MR tablet (60µg) twice daily (b.i.d.) escalating by one tablet b.i.d. each week to a maximum dose of 600µg (ten tablets) b.i.d or until the patient reaches their MTD. Following the achievement of the MTD, patients will be down-titrated off BPS-MR in weekly one tablet b.i.d. decrements. Patients may, alternatively, elect to continue taking the study drug at their MTD in a separate open-label extension study.
Interventions
- DRUG Beraprost sodium modified release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2009-01-31 |
| Est. Completion | 2010-09-30 |
| Phase | Phase 2 |
What the finished NCT00781885 record still lists
NCT00781885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Beraprost sodium modified release is the first listed.
NCT00781885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00781885 about?
NCT00781885 is a clinical study titled "A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients". This study is an international, open-label, multi-center, Phase II, multiple dose, dose-finding study to investigate the safety, tolerability and pharmacokinetic characteristics of BPS-MR tablets in male and female patients with PAH. Patients who meet the inclusion/exclusion criteria will enter the...
What is the current status of trial NCT00781885?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2009-01-31. Estimated completion is 2010-09-30.
What interventions are being tested in trial NCT00781885?
The interventions under investigation include: Beraprost sodium modified release (DRUG).
Who is sponsoring clinical trial NCT00781885?
This trial is sponsored by Lung Biotechnology PBC, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00781885's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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