Hypertension Clinical Trial
Official title:
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects With Essential Hypertension
The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan in participants with essential hypertension.
Hypertension affects approximately 50 million individuals in the United States. As the
population ages, the prevalence of hypertension will continue to increase if broad and
effective preventive measures are not implemented. According to the World Health
Organization, 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. Despite the availability of
antihypertensive treatments, hypertension remains inadequately controlled; only about
one-third of patients continue to maintain control successfully.
TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker and this study is being
conducted to evaluate the efficacy and safety of oral azilsartan medoxomil compared to
placebo and olmesartan in subjects with essential hypertension.
Individuals who want to participate in this study will be required to provide written
informed consent. Study participation is anticipated to be about 11 weeks. Multiple
procedures will occur at each visit which may include fasting, blood collection, urine
collection, vital signs including sitting blood pressure and pulse, body height and weight,
physical examinations and electrocardiograms. Outside of the study center, participants will
be required to wear an ambulatory blood pressure monitoring device at 24 hour intervals.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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