Combination of OLMesartan and CCB or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1 subtype angiotensin II receptor antagonist/low dose diuretic.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: COLM Study Research Organization
• Collaborator: Japan Heart Foundation
• Treatments: Amlodipine; Angiotensin II; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensinogen; Calcium Channel Blockers; Calcium, Dietary; Diuretics; Olmesartan; Olmesartan Medoxomil

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