Status:
COMPLETED
Combination of OLMesartan and CCB or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)
Lead Sponsor:
COLM Study Research Organization
Collaborating Sponsors:
Japan Heart Foundation
Conditions:
Hypertension
Cardiovascular Disease
Eligibility:
All Genders
65-84 years
Phase:
PHASE4
Brief Summary
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 subt...
Detailed Description
Recently, antihypertensive combination therapies have been recommended by various guidelines because of their additive effects. Combination therapies of AT1 subtype angiotensin II receptor antagonist ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
5141 Patients enrolled
Trial Details
Trial ID
NCT00454662
Start Date
April 1 2007
End Date
September 1 2011
Last Update
January 23 2013
Active Locations (1)
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1
COLM-Study Data Center
Kamiyacho Mount Bld.14F, 4-3-20 Toranomon Minato-ku, Tokyo, Japan, 105-0001