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

NCT ID: NCT00990314

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-11-30

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.

Detailed Description

Eligible patients who participated in BPS-MR-PAH-203 and who elect to continue receiving study drug in an open-label extension.Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment. Patients will be called by study personnel to assess adverse events and concomitant medications at Month 9, and at 3 month intervals following the annual visit.

At the End of Study visit, patients discontinuing study drug will be down-titrated off of BPS-MR at the discretion of the Investigator, at a maximum decrement of one tablet (60µg) b.i.d. per day and a minimum decrement of one tablet (60µg) b.i.d. per week. Likewise, patients who withdraw early from the study will be down-titrated off of BPS-MR in the same manner. Upon completion of down-titration, patients will return to the clinic for a final Closeout visit.

Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study. Patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in BPS-MR-PAH-204 main study.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

B.I.D

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

Group Type: EXPERIMENTAL

Beraprost Sodium Modified Release

Intervention Type: DRUG

Q.I.D

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

Group Type: EXPERIMENTAL

Beraprost Sodium Modified Release

Intervention Type: DRUG

Interventions

Beraprost Sodium Modified Release

Intervention Type: DRUG

Other Intervention Names

BPS-MR Tablets, 60mcg; Beraprost Sodium Modified Release Tablet, 60mcg

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lung Biotechnology PBC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aimee Smart

Role: STUDY_DIRECTOR

Study Sponsor

Locations

Harbor-UCLA Medical Center

Torrance, California, United States

Midwest Heart Foundation - Advocate Medical Group

Oakbrook Terrace, Illinois, United States

Beth Israel Medical Center

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Universite Libre de Bruxelles

Brussels, , Belgium

Catholic University of Leuven

Leuven, , Belgium

General Teaching Hospital

Prague, , Czechia

Klinikum der Universitat zu Koln

Cologne, , Germany

Medizinische Klinik und Poliklinik

Dresden, , Germany

Abt Innere Medizin III, Medizinische Universitatsklinik

Heidelberg, , Germany

Universitatsklinik Leipzig Abteilung Pulmologie

Leipzig, , Germany

Mater Misericordiae University Hospital Ltd.

Dublin, , Ireland

Institutul de Urgenta pentru Boli

Bucharest, , Romania

Institutul National de Pneumologie

Bucharest, , Romania

Institutul de Boli Cardiovasculare

Lasi, , Romania

Countries

United States; Belgium; Czechia; Germany; Ireland; Romania

Other Identifiers

BPS-MR-PAH-204

Identifier Type: -

Identifier Source: org_study_id