Olmesartan-based versus Amlodipine-based Strategies for Circulating Marker Modification in Essential Hypertension Study

UMIN ID: UMIN000000525

Registered date:21/11/2006

Basic Information

• Health condition(s) or Problem(s) studied: Essential Hypertension
• Date of first enrollment: 2006/03/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Olmesartan (max. dose=40 mg/day)-based anti-hypertensive medical therapy
Amlodipine (max. dose=10 mg/day)-based anti-hypertensive medical therapy

Outcome(s)

• Primary Outcome: (1) Cardiovascular risk marker levels (2) Changes in cardiovascular risk marker levels
• Secondary Outcome: Major cardiovascular adverse events (cardiac death, non-fatal myocardial infarction, revascularization or hospitalization by angina, hospitalization by heart failure, cerebrovascular events: cerebral infarction, cerebral hemorrhage, subarchnoidal hemorrhage)

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.Cerebrovascular and cardiovascular events including myocardial infarction, cerebral infarction, cerebral hemorrahge and subarchnoidal hemorrahge within 6 months. 2.PTCA or CABG performed within 6 months. 3.Scheduled PTCA or CABG in the future. 4.Congenital or rheumatic heart disease. 5.Severe arrhythmia. 6.Severe liver insufficiency. 7.Severe renal insufficiency. 8.Active cancer or treatment for cancer within 5 years. 9.Pregnancy, possible pregnancy. 10.Not suitable to the clinical trial as judged by a physician.

Related Information

• Primary Sponsor: Department of Cardiovascular Medicine, Kyoto University Hospital
• Source(s) of Monetary Support: Department of Cardiovascular Medicine, Kyoto University Hospital