Hypertension Clinical Trial
Official title:
A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Ramipril in Subjects With Essential Hypertension
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to ramipril for treating Essential Hypertension.
A major component of blood pressure regulation is the renin-angiotensin-aldosterone system,
a system of hormone-mediated feedback interactions that results in the relaxation or
constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide
hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting
enzyme as part of the renin-angiotensin-aldosterone system. Angiotensin II is the principal
pressor agent of the renin-angiotensin-aldosterone system with a myriad of effects on the
cardiovascular system and on electrolyte homeostasis. Two receptors for angiotensin II have
been identified. Angiotensin II type 1 receptors are located predominantly in vascular
smooth muscle, where activation by angiotensin II results in vasoconstriction, hypertrophic
proliferation, and inflammation. In contrast, stimulation of angiotensin II type 2 receptors
by angiotensin II results in vasodilatation, antiproliferative effects that are opposite
from those of angiotensin II type 1 receptor stimulation.
Drugs that modulate the renin-angiotensin-aldosterone system are used commonly worldwide for
the treatment of hypertension. Of these, some block the synthesis of angiotensin II by
inhibiting angiotensin-converting enzymes, while others inhibit the action of angiotensin II
by binding directly to the angiotensin II type 1 receptor (called angiotensin II receptor
blockers), thereby causing vasodilatation of blood vessels, resulting in a reduction in
blood pressure. The effects of angiotensin II receptor blockers on other conditions in which
the renin-angiotensin-aldosterone system plays a significant role, such as congestive heart
failure, postmyocardial infarction management and diabetic nephropathy have also been
investigated.
Although antihypertensive agents are effective at the appropriate dose, the majority have
side effects that limit their use. Angiotensin-converting enzyme inhibitors are commonly
associated with cough and more rarely with angioedema. Beta-blockers are associated with
fatigue and erectile dysfunction, calcium antagonists with peripheral edema and diuretics
with metabolic complications. As a class, angiotensin II receptor blockers generally are
considered more tolerable than other classes of hypertensive agents, although there is still
a need for compounds with improved tolerability and efficacy for the treatment of
hypertension.
TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker with high affinity for,
and selective antagonistic activity at, the angiotensin II type 1 receptor, and is being
developed for clinical use as an antihypertensive agent.
Ramipril is an angiotensin-converting enzyme inhibitor widely prescribed in Europe and Asia
for the treatment of mild to moderate essential hypertension.
This study is designed to compare the efficacy and safety/tolerability of azilsartan
medoxomil and ramipril for the treatment of hypertension.
Participants in this study will be seen twice during the first month, then once a month for
five months. Participants will also be required to fast for 8 hours prior to each visit to
the study center. Total duration of study participation is 24-weeks, plus a safety follow up
phone call after the study has ended.
;
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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