The purpose of this study is to investigate which combination therapy is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1 subtype angiotensin II receptor antagonist/low dose diuretic.
Recently, antihypertensive combination therapies have been recommended by various guidelines because of their additive effects. Combination therapies of AT1 subtype angiotensin II receptor antagonist and calcium channel blocker or low dose diuretic have shown pharmacological benefit. However, reduction of cardiovascular events and safety profile of these combination therapies under same level of antihypertensive target have not been investigated yet. In this study, primary objective is to compare two combination therapies when antihypertensive target is 140/90mmHg in elderly hypertensive patients with high cardiovascular risk. Further study details as provided by COLM-Study data center Primary Outcomes: A composite of fatal and non-fatal cardiovascular events: Sudden death (death of endogenous origin within 24 hours after acute onset); Cerebrovascular events (new occurrence or recurrence of a cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack); Coronary events (new occurrence or recurrence of a myocardial infarction, coronary revascularization\[PCI or CABG\], hospitalization for angina pectoris, hospitalization for heart failure); Renal dysfunction (doubling of serum creatinine and creatinine ≥2.0 mg/dl, end stage renal disease) Secondary Outcomes: All deaths; Death from cardiovascular events; Effects on glucose metabolism(fasting plasma glucose, postprandial glucose, new onset of diabetes mellitus); Incidence of primary outcomes events; New occurrence of atrial fibrillation; Safety; Proportion of the subjects who withdrew from the allocated treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
AT1 subtype angiotensin II receptor antagonist / calcium channel blocker : 5-40mg of olmesartan medoxomil / 2.5-5mg of amlodipine or 8-16mg of azelnidipine
AT1 subtype angiotensin II receptor antagonist / low dose diuretic : 5-40mg of olmesartan medoxomil / low dose thiazide type drug
COLM-Study Data Center
Kamiyacho Mount Bld.14F, 4-3-20 Toranomon Minato-ku, Tokyo, Japan
Composite of following events: Sudden death, Cerebrovascular events, Coronary events, Renal dysfunction
Time frame: 3 to 4.5 years (duration of planned treatment phase)
All deaths, Death from cardiovascular events, Glucose metabolism, Incidence of primary outcomes events, New onset of atrial fibrillation, Safety, Withdrawal rate
Time frame: 3 to 4.5 years (duration of planned treatment phase)
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Enrollment
5,141