The design for the double-blind, placebo-controlled Phase II exploratory study of TC-5214 provides for approximately 12 subjects with resistant hypertension to receive either a single escalating dose of TC-5214 or placebo once per week for four weeks and then a fixed daily dose of TC-5214 or placebo over the next two weeks.
The trial is being conducted at Piedmont Medical Group in Winston-Salem, North Carolina. TC-5214 is also being studied in an ongoing Phase IIb clinical trial as an augmentation therapy for major depressive disorder.
Donald deBethizy, president and CEO of Targacept, said: “We believe the unique profile of TC-5214 makes it a promising product candidate as an augmentation therapy to existing medications to help address the unmet need for patients with resistant hypertension. In addition, we remain enthusiastic about the therapeutic potential of TC-5214 as an augmentation therapy for major depressive disorder and expect to complete our ongoing Phase IIb trial in mid-2009.”