The antihypertensive efficacy and tolerability profiles of the selective AT(1) receptor antagonists telmisartan and losartan were compared with placebo in a 6-week, multinational, multicentre, randomised, double-blind, double-dummy, parallel-group study of 223 patients with mild-to-moderate hypertension, defined as clinic diastolic blood pressure (DBP) greater than or equal to 95 and less than or equal to 114 mm Hg, clinic systolic blood pressure (SBP) greater than or equal to 140 and less than or equal to 200 mm Hg, and 24-h ambulatory DBP greater than or equal to 85 mm Hg. After a 4-week single-blind placebo run-in, eligible patients were randomised to receive telmisartan 40 mg, telmisartan 80 mg, losartan 50 mg, or placebo. Ambulatory blood pressure monitoring (ABPM) after 6 weeks of double-blind therapy showed that all active treatments produced significant (P < 0.01) reductions from baseline in 24-h mean SEP and DBP compared with placebo. During the 18-to-24 h period after dosing, the reductions in SBP/DBP with telmisartan 40 nag (10.7/6.8 mm Hg) and 80 mg (12.2/7.1 mm Hg) were each significantly (P < 0.05) greater than those observed for losartan 50 mg (6.0/3.7 mm Hg), and losartan was no better than placebo. Also for the 24-h mean blood pressure, telmisartan 40 mg and 80 mg were significantly (P < 0.05) better than losartan 50 nag. compared with losartan, telmisartan 80 mg produced significantly (P < 0.05) greater reductions in both SEP and DBP during all monitored periods of the 24-h period, while telmisartan 40 mg produced significantly greater reductions in SEP and DBP in the night-time period (10.01 pm to 5.59 am) (P < 0.05) and in DBP in the morning period (6.00 am to 11.59 am) (P < 0.05). All treatments were comparably well tolerated. Telmisartan 40 mg and 80 mg once daily were effective and well tolerated in the treatment of mild-to-moderate hypertension, producing sustained 24-h blood pressure control which compared favourably with losartan.