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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled 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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Beraprost

U.S. FDA Resources

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: 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, 2010 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, 2010 or LungRx discontinues the project. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	December 2010 (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.
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

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 Rx

Investigators

Study Director:

Ted Staub, MS, MEng

Study Sponsor

More Information

No publications provided

Responsible Party:	Lung Rx ( David Armstrong, III, PhD, FACSM )
Study ID Numbers:	BPS-MR-PAH-202
Study First Received:	November 14, 2008
Last Updated:	February 23, 2010
ClinicalTrials.gov Identifier:	NCT00792571 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Hematologic Agents
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Therapeutic Uses
Beraprost
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hypertension

ClinicalTrials.gov processed this record on March 18, 2010