Combination of OLMesartan and Calcium Channel Blocker or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)
olmesartan medoxomil / amlodipine or azelnidipine
+ olmesartan medoxomil / low dose thiazide type drug
Cardiovascular Diseases+5
+ Diabetes Mellitus
+ Endocrine System Diseases
Prevention Study
Summary
Study start date: April 1, 2007
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5141 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 65 to 84 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex * Systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg in a sitting position on two consecutive measurements at clinic during use of 1 or more antihypertensive medications. * Systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg in a sitting position on two consecutive measurements at clinic without antihypertensive medication. * Require at least one of the following medical history or risk factors * Medical history * Cerebrovascular accident: cerebral infarction, brain hemorrhage, subarachnoid hemorrhage(6 months or more prior to registration) * Myocardial infarction, coronary revascularization (PCI or CABG) (6 months or more prior to registration) * Angina pectoris (except for the patients having history of hospitalization within 6 months prior to registration) * Risk factors * Male * Current diabetes mellitus, fasting glucose ≥ 110mg/dL or postprandial glucose ≥ 140mg/dl * Hypercholesterolemia (Total cholesterol ≥ 260mg/dL) * Low HDL cholesterolemia (HDL-C \<40mg/dL) * Microalbuminuria (albumin/cr ≥ 30mg/gCr) or proteinuria (protein ≥ 1+) * Left ventricular hypertrophy (ST-T change in the ECG and SV1+RV5 ≥ 35mm, or left ventricular mass index: male ≥ 125 g/m2, female ≥ 110 g/m2) Exclusion Criteria: * Secondary hypertension or malignant hypertension * History of cerebrovascular accident (including TIA) or myocardial infarction within 6 months before registration * Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) done within 6 months before registration or scheduled * History of hospitalization for angina pectoris or heart failure within 6 months before registration * Severe heart failure (New York Heart Association \[NYHA\] functional class III or more severe) * Complications of atrial fibrillation, atrial flutter or severe arrhythmia * Severe hepatic or renal dysfunction (including current treatment of dialysis or renal dysfunction with serum creatinine ≥ 2.0mg/dL) * Not appropriate for change to the study drugs from current therapy for concurrent disease including coronary diseases (i.e. calcium channel blockers, diuretics, etc) * History of serious side effect from study drugs (AT1 subtype angiotensin II receptor antagonist, calcium channel blocker, diuretic) * Life threatening condition (malignant tumor, etc) * Not suited to be study subject judged by a study physician
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
COLM-Study Data Center
Kamiyacho Mount Bld.14F, 4-3-20 Toranomon Minato-ku, JapanOpen COLM-Study Data Center in Google Maps