Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lung Biotechnology Inc.
ClinicalTrials.gov Identifier:
NCT00990314
First received: October 5, 2009
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release (BPS-MR) tablets.


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-203 in Pulmonary Arterial Hypertension (PAH) Patients

Resource links provided by NLM:


Further study details as provided by Lung Biotechnology Inc.:

Primary Outcome Measures:
  • Safety will be assessed by adverse events, physical examination, vital signs, clinical laboratory parameters, and electrocardiogram findings. [ Time Frame: 3, 6 & 12 months & annually thereafter ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Unencouraged 6-Minute Walk Test (6MWT) [ Time Frame: 3, 6 & 12 months & annually thereafter ] [ Designated as safety issue: No ]
  • Clinical Worsening [ Time Frame: 3, 6 & 12 months & annually thereafter ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 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 Tablet, 60mcg, B.I.D (twice a day dosing)
Drug: Beraprost Sodium Modified Release
Other Names:
  • BPS-MR Tablets, 60mcg
  • Beraprost Sodium Modified Release Tablet, 60mcg
Experimental: Q.I.D
Beraprost Sodium Modified Release Tablet, 60mcg, q.i.d (four times a day dosing)
Drug: Beraprost Sodium Modified Release
Other Names:
  • BPS-MR Tablets, 60mcg
  • Beraprost Sodium Modified Release Tablet, 60mcg

Detailed Description:

Eligible patients who participated in BPS-MR-PAH-203 and who elect to continue receiving study drug in an open-label extension.Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment. Patients will be called by study personnel to assess adverse events and concomitant medications at Month 9, and at 3 month intervals following the annual visit.

At the End of Study visit, patients discontinuing study drug will be down-titrated off of BPS-MR at the discretion of the Investigator, at a maximum decrement of one tablet (60µg) b.i.d. per day and a minimum decrement of one tablet (60µg) b.i.d. per week. Likewise, patients who withdraw early from the study will be down-titrated off of BPS-MR in the same manner. Upon completion of down-titration, patients will return to the clinic for a final Closeout visit.

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-204 main study.

  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 203 are eligible for this study.
  • Women of child-bearing potential (defined as less than 1 year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence. If sexually active, female patients must use a double barrier method of birth control, such as a condom and spermicidal.

Exclusion Criteria:

  • Patients who discontinued study drug during the previous study (BPS MR PAH 203) 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: NCT00990314

Locations
United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Illinois
Midwest Heart Foundation - Advocate Medical Group
Oakbrook Terrace, Illinois, United States, 60181
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Beth Israel Medical Center
New York, New York, United States, 10003
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Belgium
Universite Libre de Bruxelles
Bruxelles, Belgium, 1070
Catholic University of Leuven
Leuven, Belgium, 3000
Czech Republic
General Teaching Hospital
Praha, Czech Republic, 2, 128 08
Germany
Klinikum der Universitat zu Koln
Cologne, Germany, 50937
Medizinische Klinik und Poliklinik
Dresden, Germany, 01307
Abt Innere Medizin III, Medizinische Universitatsklinik
Heidelberg, Germany, 69120
Universitatsklinik Leipzig Abteilung Pulmologie
Leipzig, Germany, 04103
Ireland
Mater Misericordiae University Hospital Ltd.
Dublin, Ireland, 7
Romania
Institutul National de Pneumologie
Bucuresti, Romania, 050159
Institutul de Urgenta pentru Boli
Bucuresti, Romania, 022322
Institutul de Boli Cardiovasculare
Lasi, Romania, 700503
Sponsors and Collaborators
Lung Biotechnology Inc.
Investigators
Study Director: Aimee Smart Study Sponsor
  More Information

No publications provided

Responsible Party: Lung Biotechnology Inc.
ClinicalTrials.gov Identifier: NCT00990314     History of Changes
Other Study ID Numbers: BPS-MR-PAH-204
Study First Received: October 5, 2009
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Beraprost
Epoprostenol
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 19, 2014