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

Purpose

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

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Beraprost Sodium Modified Release	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

U.S. FDA Resources

Further study details as provided by Lung Biotechnology PBC:

Primary Outcome Measures:

The primary outcome is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in BPS-MR-PAH-201 study [ Time Frame: 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, 2014 or LungRx discontinues the project. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test, the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS-MR-PAH-201 study. [ Time Frame: 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, 2014 or LungRx discontinues the project. ] [ Designated as safety issue: Yes ]


Enrollment:	18
Study Start Date:	February 2009
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: B.I.D Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)	Drug: Beraprost Sodium Modified Release Other Names: BPS-MR Tablets, 60 mcg Beraprost Sodium Modified Release Tablet, 60 mcg
Experimental: Q.I.D Beraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing)	Drug: Beraprost Sodium Modified Release Other Names: BPS-MR Tablets, 60 mcg Beraprost Sodium Modified Release Tablet, 60 mcg

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792571

Locations


United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
UTSW Medical Center Dallas
Dallas, Texas, United States, 75390-8550
Belgium
Universite Libre de Bruxelles
Bruxelles, Belgium
Gastuisberg University Hospital
Leuven, Belgium
Ireland
Mater Misericordiae University Hospital Ltd.
Dublin, Ireland

Sponsors and Collaborators

Lung Biotechnology PBC

Investigators


Study Director:	Aimee Smart	Study Sponsor

More Information


Responsible Party:	Lung Biotechnology PBC
ClinicalTrials.gov Identifier:	NCT00792571 History of Changes
Other Study ID Numbers:	BPS-MR-PAH-202
Study First Received:	November 14, 2008
Last Updated:	May 19, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases	Respiratory Tract Diseases Beraprost Epoprostenol Platelet Aggregation Inhibitors Vasodilator Agents Antihypertensive Agents

ClinicalTrials.gov processed this record on September 27, 2016