BioMarin Pharmaceutical has announced that the first patient has initiated treatment in the Phase II clinical study of 6R-BH4 for the treatment of poorly controlled hypertension. The company expects to announce data from this study in early 2007.
The multicenter, double-blind, placebo-controlled, parallel-group study is designed to evaluate the safety and efficacy of 6R-BH4 on blood pressure in patients with poorly controlled systemic hypertension. The study will be conducted at up to 25 sites in the U.S. and will enroll approximately 84 patients, with the intention that approximately half of the patients will have Type 2 diabetes. Patients must have elevated blood pressure and be on at least two different medications for hypertension. Study patients will receive oral doses of 5 mg/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. The primary endpoint analysis will compare the mean change in SBP between the 6R-BH4 and placebo groups. A secondary endpoint analysis will compare the mean change in diastolic blood pressure between the 6R-BH4 and placebo groups.