Clinical trial NCT00990314: Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients
Official title: An Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Lung Biotechnology PBC
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to 42 months
measure: Number of Reported Treatment-Emergent Adverse Events
timeFrame: Up to 42 months
Secondary outcomes:
measure: Change in Six-Minute-Walk Distance (6MWD)
timeFrame: Baseline and 42 months
measure: Change in Borg Dyspnea Score
timeFrame: Baseline and 42 months
measure: Number of Participants That Experienced Clinical Worsening
timeFrame: Up to 42 months
measure: Number of Participants With a Change in WHO Functional Class
timeFrame: Baseline and 42 months
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Oakbrook Terrace
country: United States
facility: Midwest Heart Foundation - Advocate Medical Group
state: Illinois
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Bruxelles
country: Belgium
facility: Universite Libre de Bruxelles
city: Leuven
country: Belgium
facility: Catholic University of Leuven
city: Praha
country: Czechia
facility: General Teaching Hospital
city: Cologne
country: Germany
facility: Klinikum der Universitat zu Koln
city: Dresden
country: Germany
facility: Medizinische Klinik und Poliklinik
city: Heidelberg
country: Germany
facility: Abt Innere Medizin III, Medizinische Universitatsklinik
city: Leipzig
country: Germany
facility: Universitatsklinik Leipzig Abteilung Pulmologie
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital Ltd.
city: Bucuresti
country: Romania
facility: Institutul de Urgenta pentru Boli
city: Bucuresti
country: Romania
facility: Institutul National de Pneumologie
city: Lasi
country: Romania
facility: Institutul de Boli Cardiovasculare
Study officials:
affiliation: Study Sponsor
name: Aimee Smart
role: STUDY_DIRECTOR
References: