Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Subjects With Moderate to Severe Hypertension
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Hypertension
Intervention
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
Location
Birmingham
Alabama
United States
Status
Completed
Source
Takeda Global Research & Development Center, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00847626
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Chlorthalidone
A benzenesulfonamide-phthalimidine that tautomerizes to a BENZOPHENONES form. It is considered a thiazide-like diuretic.
Clinical Trials
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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...
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PubMed Articles
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Drug therapy often fails to control hypertension. Azilsartan medoxomil (AZL-M) is a newly developed angiotensin II receptor blocker with high efficacy and good tolerability. This double-blind, control...
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Olmesartan medoxomil: in children and adolescents with hypertension.
Olmesartan medoxomil is an orally administered angiotensin II receptor antagonist, selective for the angiotensin II type 1 receptor, which has established antihypertensive efficacy in adults. In child...
