Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Lung Biotechnology PBC. The registered enrollment target is 19 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00781885
The ClinicalTrials.gov registry entry for NCT00781885 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lung Biotechnology PBC, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Beraprost sodium modified release is the first listed.
NCT00781885 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.