Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients

NCT00990314 | Completed Phase 2 Results

• 1 other identifier: BPS-MR-PAH-204
• Study Type: interventional
• Target: 31
• Locations: 6 countries
• Sites: 17

Brief Summary

This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release (BPS-MR) tablets.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

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

  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not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 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

  Up to 42 months

• Number of Reported Treatment-Emergent Adverse Events

  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not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 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.

  Up to 42 months

Secondary Outcomes (4)

• Change in Six-Minute-Walk Distance (6MWD)

  Baseline and 42 months

• Change in Borg Dyspnea Score

  Baseline and 42 months

• Number of Participants That Experienced Clinical Worsening

  Up to 42 months

• Number of Participants With a Change in WHO Functional Class

  Baseline and 42 months

Study Arms (2)

B.I.D

EXPERIMENTAL

Beraprost Sodium Modified Release Tablet, 60mcg, B.I.D (twice a day dosing)

Drug: Beraprost Sodium Modified Release

Q.I.D

EXPERIMENTAL

Beraprost Sodium Modified Release Tablet, 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, 60mcg, Beraprost Sodium Modified Release Tablet, 60mcg

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 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 a double barrier method of birth control, such as a condom and spermicidal.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lung Biotechnology PBC: lead

Study Sites (17)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Midwest Heart Foundation - Advocate Medical Group

Oakbrook Terrace, Illinois, 60181, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Universite Libre de Bruxelles

Brussels, 1070, Belgium

Location

Catholic University of Leuven

Leuven, 3000, Belgium

Location

General Teaching Hospital

Prague, 2, 128 08, Czechia

Location

Klinikum der Universitat zu Koln

Cologne, 50937, Germany

Location

Medizinische Klinik und Poliklinik

Dresden, 01307, Germany

Location

Abt Innere Medizin III, Medizinische Universitatsklinik

Heidelberg, 69120, Germany

Location

Universitatsklinik Leipzig Abteilung Pulmologie

Leipzig, 04103, Germany

Location

Mater Misericordiae University Hospital Ltd.

Dublin, 7, Ireland

Location

Institutul de Urgenta pentru Boli

Bucharest, 022322, Romania

Location

Institutul National de Pneumologie

Bucharest, 050159, Romania

Location

Institutul de Boli Cardiovasculare

Lasi, 700503, Romania

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: October 5, 2009
• First Posted: October 6, 2009
• Study Start: November 30, 2009
• Primary Completion: November 30, 2013
• Study Completion: November 30, 2013
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-09

Locations

RO (3); CZ (1); US (6); DE (4); IE (1); BE (2)