Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug
alone, often a combination of two or more drugs is essential to achieve a sufficient
antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination
therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low
dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the
Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination
(FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure
(DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with
T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.
In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood
pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination
was shown (U07-3503-02). But the sponsor has no data that verifies this difference in
Japanese patients.
Thus, this clinical trial is being conducted to investigate the antihypertensive effect and
safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients
with essential hypertension. In this trial, a multi-centre, randomised, double-blind,
double-dummy, active-controlled, parallel group comparison method is employed.