An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAD)
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 BPS-MR tablets. Patients will begin the study at the final, twice daily (b.i.d.) dose achieved during their participation in the BPS-MR-PAH-203 study.
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 (60[MICRO-SYMBOL]g) b.i.d. per day and a minimum decrement of one tablet (60[MICRO-SYMBOL]g) 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. Patients transitioning to a commercial drug product (if available) at the End of Study visit will not require a Closeout visit.
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.