The study will be conducted at up to 25 sites in the US and will enroll approximately 84 patients, with the intention that approximately half of the patients will have type 2 diabetes. Among other eligibility criteria, to participate in the study, patients must have elevated blood pressure while on at least two different medications for hypertension.
Study patients will receive oral doses of 5mg/kg of 6R-BH4 or a placebo twice daily for an eight-week period. The primary endpoint variable of the study is the change in systolic blood pressure (SBP) from baseline to week eight.
“Our goal is to confirm results seen earlier in pilot clinical studies that demonstrated that oral administration of 6R-BH4 can reduce blood pressure in individuals who remain hypertensive despite treatment with other medications,” stated Dr Emil Kakkis, chief medical officer of BioMarin.