The Japan-Combined Treatment With Olmesartan and a Calcium Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study (J-CORE)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (BP) and reducing target organ damage in Japanese hypertensive patients: Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics.

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

Details

• Lead Sponsor: Jichi Medical University
• Treatments: Calcium Channel Blockers; Diuretics; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Criteria

Inclusion Criteria:

• Hypertensive outpatients aged 30 years or older, and less than 85 years (at the time of informed consent), regardless of sex

• Office systolic BP/diastolic BP > 140/90 mmHg in a sitting position even if on treatment with olmesartan 20 mg/day for 3 months.

Exclusion Criteria:

• Secondary hypertension or malignant hypertension

• History of myocardial infarction or cerebrovascular accidents within 6 months prior to the screening

• Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) done within 6 months of screening or scheduled

• Current treatment for congestive cardiac failure (New York Heart Association [NYHA] functional class II or severer) or ejection fraction <40%

• Atrial fibrillation or atrial flutter

• Renal dysfunction (serum creatinine ≥2 mg/dl)

• Hepatic dysfunction (AST and/or ALT ≥100 IU/l)