Hypertension Clinical Trial
Official title:
A Randomised, Double-Blind, Placebo-Controlled, 3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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