Pulmonary Arterial Hypertension Clinical Trial
Official title:
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 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.
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. All patients will be
receiving background therapy with either a phosphodiesterase (PDE-5) inhibitor, endothelin
receptor antagonist (ERA), or the combination of these two.
The study is divided into two phases:
1. The Treatment Phase and
2. The Down-Titration Phase
Screening will be conducted on an outpatient basis within 21 days prior to the Baseline
visit. Patients meeting the inclusion/exclusion criteria at the Baseline visit will enter the
Treatment Phase and begin taking one BPS-MR tablet (60µg) b.i.d. and 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
an intolerable dose.
Patients who reach an intolerable dose will be instructed to continue treatment at the
previous dose, which will be considered as their individual MTD. For example, if a patient
attains a full week of six BPS-MR tablets b.i.d. (360µg) but is unable to tolerate seven
tablets (420µg) then the patient will return to using six tablets of BPS-MR b.i.d. (360µg)
for up to an additional week of treatment. In this scenario, BPS-MR 360µg b.i.d. is the
patient's MTD. Patients who do not reach an intolerable dose and tolerate the full ten weeks
of BPS-MR dosing will be considered to have their individual MTD as BPS-MR 600µg b.i.d.
When patients reach their individual MTD (either at 10 weeks or earlier) they will return to
the site 3-7 days after for an End of Treatment Phase assessment to be evaluated for safety
and, optionally, a PK assessment. Subsequent to the End of Treatment Phase visit patients
will be instructed to begin down-titration off of BPS-MR in weekly increments. However,
patients may alternatively elect to continue taking BPS-MR at their MTD in a separate
open-label extension study.
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