We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00792571
First Posted: November 18, 2008
Last Update Posted: May 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lung Biotechnology PBC
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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. ]

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. ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 14, 2008
First Posted: November 18, 2008
Last Update Posted: May 29, 2014
Last Verified: May 2014

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