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

NCT ID: NCT00792571

Last Updated: 2019-12-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment.

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-202 main study.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B.I.D

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

Group Type EXPERIMENTAL

Beraprost Sodium Modified Release

Intervention Type DRUG

Interventions

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Beraprost Sodium Modified Release

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lung Biotechnology PBC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aimee Smart

Role: STUDY_DIRECTOR

Study Sponsor

Locations

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Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UTSW Medical Center Dallas

Dallas, Texas, United States

Site Status

Universite Libre de Bruxelles

Brussels, , Belgium

Site Status

Gastuisberg University Hospital

Leuven, , Belgium

Site Status

Mater Misericordiae University Hospital Ltd.

Dublin, , Ireland

Site Status

Countries

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United States Belgium Ireland

Other Identifiers

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BPS-MR-PAH-202

Identifier Type: -

Identifier Source: org_study_id