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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607035
• Other study ID #: J_Core_071226
• Secondary ID: J_Core_071226_01
• Status: Completed
• Phase: Phase 4
• First received: December 26, 2007
• Last updated: November 19, 2008
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Jichi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

Renin-angiotensin (RA) inhibitors have been demonstrated to be the most effective drugs for reducing subclinical target organ damage in hypertensive patients. In several patients, however, BP control is not sufficiently achieved by RA inhibitors alone, and a combination of two drugs is frequently required. It is unclear whether a combination of RA inhibitors and diuretics or CCB is more effective in reducing hypertensive target organ damage. Control of central BP has been shown to be more effective than peripheral BP in predicting cardiovascular events and target organ damage associated with hypertension. The J-CORE study is active controlled, 2-arm parallel group comparison, prospective randomized open blinded end-point (PROBE) design study. The ARB plus CCB combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day and the ARB plus diuretics combination therapy group receives olmesartan 20 mg/day and hydrochlorothiazide (HCTZ) 12.5 mg/day. At least 100 patients will be enrolled in each group and the follow up duration will be 24 weeks. The primary endpoint is to compare the changes in the central aortic BP and the ambulatory BP between the two groups. The secondary endpoint is to compare the changes in office BP, home BP, and hypertensive target organ damage between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Olmesartan medoxomil +Azelnidipine
The ARB plus CCB combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day for 6 months.
• Olmesartan medoxomil + Hydrochlorothiazide
The ARB plus Diuretics combination therapy group is administered olmesartan medoxomil 20mg/day and hydrochlorothiazide 12.5mg/day for 6 months.

Locations

Country	Name	City	State
Japan	Jichi Medical University School of Medicine	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
Jichi Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in central BP and ambulatory BP		6 months	Yes
Secondary	Changes in office BP and home BP.		6 months	Yes
Secondary	Changes in hypertensive target organ damage. Clinical laboratory data.		6 months	Yes