P-242: An 8-week, double-blind, placebo-controled, multicenter, Ambulatory Blood Pressure Monitoring (ABPM) study of Teveten (Eprosartan Mesylate) 600mg and 1200mg QD in patients with essential hypertension

This was a double-blinded, placebo-controlled, parallel group, multicenter study in patients with essential hypertension (SitDBP > 95 mmHg and ≤114 mmHg). The study was composed of a 2–4 week placebo run-in period, an 8-week double-blind treatment period, and a 5–7 day post-dose follow-up period. Eligible patients were randomized to receive placebo, Teveten 600mg QD, or Teveten 1200mg QD for 8 weeks and returned 2, 4 and 8 weeks after randomization for evaluation. 24 ABPM was performed on all patients. The total number of randomized patients was 200, with 67 in the placebo group, 62 in the Teveten 600 mg group and 71 in the Teveten 1200 mg group. Following a single-blind placebo run-in period lasting 2–4 weeks, patients were randomized to double-blind treatment with placebo, Tevetn 600 mg QD, or Teveten 1200 mg QD for 8 weeks. Study medication was taken once daily in the morning. Teveten was supplied as 300 mg tablets with corresponding placebo tablets. During the placebo run-in period, all patients took 4 placebo tablets corresponding to Teveten 300 mg tablets. During the double-blind period, placebo patients took 4 placebo tablets corresponding to Teveten 300 mg; patients randomized to Teveten 600 mg took 2 Teveten 300 mg tablets and 2 corresponding placebo tablets; patients randomized to Teveten 1200 mg took 4 Teveten 300 mg tablets. Teveten, when administered 600 mg, as well as, 1200 m once daily, statistically significantly lowered mean 24-hour Ambulatory DBP when compared with placebo (p