An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients

NCT00792571 | Completed Phase 2 Results

• 1 other identifier: BPS-MR-PAH-202
• Study Type: interventional
• Target: 18
• Locations: 3 countries
• Sites: 6

Brief Summary

This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE)

  A treatment-emergent adverse event (TEAEs) is defined as an event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. AEs occurring more than 3 days after the last day study drug is taken in the study will not be included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only treatment-emergent adverse events occurring during the treatment period of the BPS-MR-PAH-202 study will be summarized. Any adverse event starting prior to the first dose of study drug will be excluded from the summary analyses and only presented in the data listings. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  Up to 56 months

• Number of Treatment Emergent Adverse Events Reported During The Study

  A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for participants with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-202 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  Up to 56 months

Secondary Outcomes (4)

• Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at End of Study

  Baseline and 56 months

• Change From Baseline in Borg Dyspnea Score at End of Study

  Baseline and 56 months

• Number of Participants That Experienced Clinical Worsening During the Study

  Up to 56 months

• Number of Participants With a Change in WHO Functional Class

  Baseline and 56 months

Study Arms (2)

B.I.D

EXPERIMENTAL

Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)

Drug: Beraprost Sodium Modified Release

Q.I.D

EXPERIMENTAL

Beraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing)

Drug: Beraprost Sodium Modified Release

Interventions

Beraprost Sodium Modified Release DRUG

Also known as: BPS-MR Tablets, 60 mcg, Beraprost Sodium Modified Release Tablet, 60 mcg

B.I.D; Q.I.D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS-MR-PAH-201 are eligible for this study.
• Female patients must either be physiologically incapable of childbearing or be practicing an acceptable method of birth control (e.g. approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or an intrauterine device).

You may not qualify if:

• Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) 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.

Sponsors & Collaborators

• Lung Biotechnology PBC: lead

Study Sites (6)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UTSW Medical Center Dallas

Dallas, Texas, 75390-8550, United States

Location

Universite Libre de Bruxelles

Brussels, Belgium

Location

Gastuisberg University Hospital

Leuven, Belgium

Location

Mater Misericordiae University Hospital Ltd.

Dublin, Ireland

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Lung Biotechnology PBC Study Director
• Organization: Lung Biotechnology PBC

301-608-9292

Study Officials

• Aimee Smart

  Study Sponsor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 18, 2008
• Study Start: February 28, 2009
• Primary Completion: November 30, 2013
• Study Completion: November 30, 2013
• Last Updated: December 26, 2019
• Results First Posted: December 26, 2019

Record last verified: 2019-12

Locations

IE (1); US (3); BE (2)