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Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)
NCT00989963 · View on ClinicalTrials.gov ↗
Study Summary
This is a 12-week, international, multicenter, double-blind, three-group, dose-response study to assess the safety and efficacy of BPS-MR in patients with PAH. Eligible patients will have been previously diagnosed with PAH and will be on a stable course of an ERA and/or PDE-5 inhibitor for at least 60 days prior to Baseline. Patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio and will be stratified by PAH background therapy (Endothelium Receptor Antagonist (ERA), Phosphodiesterase-5 (PDE-5), and both). The treatment groups consist of one Maximum Tolerated Dose (MTD) and two Fixed Dose (FD) groups. Following randomization, patients will begin taking active drug (60µg) orally twice daily. Patients will visit their investigational site at Week 6 and Week 12 for study evaluations.
Conditions Studied
Interventions
- DRUG Beraprost Sodium Modified Release
Study Locations (17)
Other
- Universite Libre de Bruxelles — Bruxellas
- Catholic University of Leuven — Leuven
- General Teaching Hospital — Prague
- Klinikum der Universitat zu Koln — Cologne
- Medizinische Klinik und Poliklinik — Dresden
- Abt. Innere Medizin III, Medizinische Universitatsklinik — Heidelberg
- Universitatsklinik Leipzig Abteilung Pulmologie — Leipzig
- Mater Misericordiae University Hospital Ltd. — Dublin
- Institutul de Urgenta pentru Boli — Bucharest
- Institutul National de Pneumologie — Bucharest
- Institutul de Boli Cardiovasculare — Lasi
New York
- Beth Israel Medical Center — New York
- Albert Einstein College of Medicine — The Bronx
California
- Harbor-UCLA Medical Center — Torrance
Illinois
- Edward Heart Hospital — Naperville
Pennsylvania
- Allegheny General Hospital — Pittsburgh
Texas
- UT Southwestern Medical Center — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-02-01 |
| Est. Completion | 2011-09-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00989963
The ClinicalTrials.gov registry entry for NCT00989963 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lung Biotechnology PBC, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 1 intervention — of which Beraprost Sodium Modified Release is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00989963 reports 17 study locations spanning 6 distinct geographic areas — top geographies include Other, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00989963 about?
NCT00989963 is a clinical study titled "Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)". This is a 12-week, international, multicenter, double-blind, three-group, dose-response study to assess the safety and efficacy of BPS-MR in patients with PAH. Eligible patients will have been previously diagnosed with PAH and will be on a stable course of an ERA and/or PDE-5 inhibitor for at least ...
What is the current status of trial NCT00989963?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-02-01. Estimated completion is 2011-09-13.
What conditions does trial NCT00989963 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00989963?
The interventions under investigation include: Beraprost Sodium Modified Release (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00989963?
This trial is sponsored by Lung Biotechnology PBC, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00989963 being conducted?
This trial has 17 study locations across California, Illinois, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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