Hypertension Clinical Trial
Official title:
Combination of OLMesartan and Calcium Channel Blocker or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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