Clinical trial NCT00792571: An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
Official title: An Open-Label Extension of BPS-MR-PAH-201 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: 2008-11-18
Enrollment: 18
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 extension study for patients who participated in the BPS-MR-PAH-201 study.

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 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.

Primary outcomes:
measure: Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to 56 months
measure: Number of Treatment Emergent Adverse Events Reported During The Study
timeFrame: Up to 56 months
Secondary outcomes:
measure: Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at End of Study
timeFrame: Baseline and 56 months
measure: Change From Baseline in Borg Dyspnea Score at End of Study
timeFrame: Baseline and 56 months
measure: Number of Participants That Experienced Clinical Worsening During the Study
timeFrame: Up to 56 months
measure: Number of Participants With a Change in WHO Functional Class
timeFrame: Baseline and 56 months
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UTSW Medical Center Dallas
state: Texas
city: Bruxelles
country: Belgium
facility: Universite Libre de Bruxelles
city: Leuven
country: Belgium
facility: Gastuisberg University Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital Ltd.
Study officials:
affiliation: Study Sponsor
name: Aimee Smart
role: STUDY_DIRECTOR
References: