Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Subjects With Moderate to Severe Hypertension
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in subjects with moderate to severe hypertension.
According to the World Health Organization (WHO), hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. Despite the availability of antihypertensive agents, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully.
Although most antihypertensive agents are effective at the appropriate dose, the majority have side effects that limit their use. As a class, angiotensin II receptor blockers generally are considered more tolerable than other classes of antihypertensive agents. TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker that is being evaluated by Takeda to treat essential hypertension.
Treatments for essential hypertension commonly include use of a thiazide-type diuretic, either alone or as part of combination treatment.
This study is designed to compare the antihypertensive effect and the safety and tolerability of the azilsartan medoxomil plus chlorthalidone fixed-dose combination product (TAK 491CLD FDC) with azilsartan monotherapy and chlorthalidone monotherapy during 8 weeks of treatment.
Subjects participating in this study will be randomized to receive one of 11 possible dosing combinations of azilsartan medoxomil , chlorthalidone and placebo over an 8 week period. The total duration of the study will be approximately 13 weeks. Subjects will make 12 visits to the clinic. Each subject will also be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and chlorthalidone, Chlorthal
Takeda Global Research & Development Center, Inc.
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00847626
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A benzenesulfonamide-phthalimidine that tautomerizes to a BENZOPHENONES form. It is considered a thiazide-like diuretic.
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in subjects with moderate to severe essential hyper...
The purpose of this study is to evaluate the effectiveness and safety of Azilsartan Medoxomil in African-American subjects with essential hypertension.
The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to olmesartan in subjects with essential hypertension.
The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil, once daily (QD), in African-American subjects with essential hypertension.
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