1. To investigate the dose response of the combination therapy, Telmisartan and Hydrochlorothiazide for the Japanese patients with Essential Hypertension. 2. To compare this dose response with that in the US study.
This is an 8-week multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group study utilizing all cells of a 3 x 3 factorial design. Following Screening examinations and a 4-week Placebo Run-In Period, 540 patients will be randomized to receive once-daily monotherapy with either telmisartan (MICARDIS), hydrochlorothiazide, placebo, or combination therapy with telmisartan and hydrochlorothiazide for 8 weeks (Treatment Period). This study includes nine cells, placebo, telmisartan (TEL) 40 mg, TEL 80 mg, hydrochlorothiazide (HCTZ) 6.25 mg, HCTZ 12.5 mg, TEL 40 mg/HCTZ 6.25 mg, TEL 40 mg/HCTZ 12.5 mg, TEL 80 mg/HCTZ 6.25 mg, and TEL 80 mg/HCTZ 12.5 mg. Study Hypothesis: The hypothesis is that the dose response model for the Japanese patient with essential hypertension which is constructed for the change of the supine diastolic blood pressure from the baseline value to end of treatment with the multiple regression analysis, is similar to that in the US study 502.204. Comparison(s): The primary efficacy parameter will be the change from baseline in supine diastolic blood pressure at trough (24 hours post-dose) at the last visit during the Double-Blind Period. The dose response surface model will be constructed. The graphs of dose response surface will be generated based on the final model. The model in this study will compare with that in US study from the perspective of including the same terms in the model.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
583
Boehringer Ingelheim Investigational Site
Annaka, Gunma, Japan
Change from baseline in supine diastolic blood pressure (DBP) at trough (24 hours post-dose)
Time frame: after 8 weeks
Change in supine systolic blood pressure (SBP) at trough (24 hours post-dose)
Time frame: after 8 weeks
Change in sitting systolic and diastolic blood pressure at trough (24 hours post-dose)
Time frame: after 8 weeks
DBP control rate
Time frame: after 8 weeks
DBP response rate
Time frame: after 8 weeks
SBP response rate
Time frame: after 8 weeks
Incidence of adverse events
Time frame: up to 8 weeks
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Boehringer Ingelheim Investigational Site
Asahi,Chiba, Japan
Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
Boehringer Ingelheim Investigational Site
Ichinomiya, Aichi, Japan
Boehringer Ingelheim Investigational Site
Iida,Nagano, Japan
Boehringer Ingelheim Investigational Site
Inzai, Chiba, Japan
Boehringer Ingelheim Investigational Site
Isesaki, Gunma, Japan
Boehringer Ingelheim Investigational Site
Kako-gun, Hyogo, Japan
Boehringer Ingelheim Investigational Site
Kasuya-gun,Fukuoka, Japan
...and 14 more locations