[Multi-national clinical trial in circulatory disorders].

As Japan becomes more integrated into the global market, pharmaceutical research and development (R&D) in Japan faces considerable challenges. While global simultaneous development including Asian countries has become a common strategy for multi-national pharmaceutical companies, Japan has been frequently set aside because of its provincial regulatory and clinical trial infrastructure. Meanwhile, many improvement programs in pharmaceutical area have been initiated in Japan.

Antihypertensive efficacy and safety of fixed-dose combination therapy with losartan plus hydrochlorothiazide in Japanese patients with essential hypertension.

A randomized, double-blind, placebo-controlled, parallel-group multicenter study was conducted to evaluate the antihypertensive efficacy and safety of 8-week treatment with one of three fixed-dose combinations-losartan 50 mg plus hydrochlorothiazide 12.5 mg, losartan 50 mg plus hydrochlorothiazide 6.25 mg, or losartan 25 mg plus hydrochlorothiazide 6.

Finasteride in the treatment of Japanese men with male pattern hair loss.

Finasteride is a type 2 5 alpha-reductase inhibitor that inhibits conversion of testosterone to dihydrotestosterone, a key mediator of male pattern hair loss (androgenetic alopecia). The objective of this study was to identify the optimal dosage of finasteride and to evaluate its efficacy and safety in the treatment of Japanese men with male pattern hair loss. In this double- blind randomized study, 414 Japanese men with male pattern hair loss received finasteride 1 mg (n = 139), finasteride 0.