An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014453-32-IE

Enrollment

Registered

2009-11-09

Start date

2010-02-01

Completion date

Unknown

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Beraprost Sodium CAS Number: 88475-69-8 Current Sponsor code: BPS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS MR PAH 203 are eligible for this study. Women of child-bearing potential (defined as less than 1 year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence. If sexually active, female patients must use two highly effective methods of birth control. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who discontinued study drug during the previous study (BPS MR PAH 203) 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in the BPS MR PAH 203 study. ;Secondary Objective: The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test (6MWT), the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS MR PAH 203 study. ;Primary end point(s): In order to evaluate the long-term safety and efficacy of BPS-MR, the study is expected to continue until the first of either of the following is reached: December 31, 2011, or Lung LLC discontinues the project.	—

Measure

Time frame

Main Objective: The primary objective is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in the BPS MR PAH 203 study. ;Secondary Objective: The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test (6MWT), the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS MR PAH 203 study. ;Primary end point(s): In order to evaluate the long-term safety and efficacy of BPS-MR, the study is expected to continue until the first of either of the following is reached: December 31, 2011, or Lung LLC discontinues the project.

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Countries

Belgium, Czech Republic, Germany, Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026