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

Sponsored by:	Lung Rx
Information provided by:	Lung Rx
ClinicalTrials.gov Identifier:	NCT00792571

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 II

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Beraprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.

Further study details as provided by Lung Rx:

Primary Outcome Measures:

The primary objective is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in the BPS-MR-PAH-201 study. [ Time Frame: Until the commercial product is available for purchase in the appropriate region or Lung Rx 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: Until the commercial product is available for purchase in the appropriate region or Lung Rx discontinues the project. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Tablets 60mcg b.i.d.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
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.

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

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

Sponsors and Collaborators

Lung Rx

Investigators

Study Director:

Ted Staub, MS, MEng

Study Sponsor

More Information

Responsible Party:	Lung Rx ( David Armstrong, III, PhD, FACSM )
Study ID Numbers:	BPS-MR-PAH-202
Study First Received:	November 14, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00792571
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Beraprost
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2009