Safety Clinical Trial
Official title:
A Randomized, Open-Label, Phase 3 Study to Compare Long-Term Safety and Tolerability of the TAK-491 and Chlorthalidone Fixed-Dose Combination Versus Olmesartan Medoxomil and Hydrochlorothiazide Fixed-Dose Combination in Hypertensive Subjects With Moderate Renal Impairment
The purpose of this study is to evaluate long term safety and tolerability of azilsartan medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and hydrochlorothiazide in hypertensive participants with moderate renal impairment.
A major component of blood pressure regulation is the renin-angiotensin-aldosterone system
(RAAS). Drugs that modulate the RAAS are used commonly worldwide for the treatment of
hypertension. TAK-491 (azilsartan medoxomil) is a prodrug of TAK-536 (azilsartan), an
angiotensin II receptor blocker (ARB). Azilsartan medoxomil is being evaluated by Takeda to
treat participants with essential hypertension.
Chlorthalidone is an orally administered thiazide-like diuretic agent, and long-term
outcomes trials show blood pressure reductions associated with chlorthalidone treatment
reduce risk of cardiovascular morbidity and mortality.
Hypertensive patients with moderate renal impairment are a relatively more severe and
resistant hypertension population, and may benefit from effective fixed-dose combination
treatments such as an ARB plus a diuretic for blood pressure control.
Participants will be randomized to receive azilsartan medoxomil and chlorthalidone or
olmesartan medoxomil and hydrochlorothiazide for up to 52 weeks to evaluate long term safety
of azilsartan medoxomil and chlorthalidone. A titration-to-target blood pressure approach
will be used to guide the titration of study medication in this trial.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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