If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an
antihypertensive drug from different class should be started concomitantly.
In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential
hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg,
the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg
monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan
80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her
blood pressure controlled with telmisartan 80 mg.
Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and
safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different
pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with
telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who
fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg
monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy,
active-controlled, parallel group comparison method is employed.