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

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ClinicalTrials.gov Identifier: NCT00607035
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : November 20, 2008
Sponsor:
Information provided by:
Jichi Medical University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Olmesartan medoxomil ＋Azelnidipine Drug: Olmesartan medoxomil + Hydrochlorothiazide Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Japan-Combined Treatment With Olmesartan and a Calcium Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study (J-CORE)
Study Start Date : May 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
The ARB plus CCB combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day for 6 months.
 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.
Other Name: arm A
Experimental: H
The ARB plus Diuretics combination therapy group is administered olmesartan medoxomil 20mg/day and hydrochlorothiazide 12.5mg/day for 6 months.
 Drug: Olmesartan medoxomil + Hydrochlorothiazide
The ARB plus Diuretics combination therapy group is administered olmesartan medoxomil 20mg/day and hydrochlorothiazide 12.5mg/day for 6 months.
Other Name: arm H


Outcome Measures
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Primary Outcome Measures :
  1. Changes in central BP and ambulatory BP [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Changes in office BP and home BP. [ Time Frame: 6 months ]
  2. Changes in hypertensive target organ damage. Clinical laboratory data. [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607035


Locations
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Japan
Jichi Medical University School of Medicine
Tochigi, Japan
Sponsors and Collaborators
Jichi Medical University
Investigators
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Principal Investigator: Kazuomi Kario Jichi Medical University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kazuomi Kario, Jichi Medical University
ClinicalTrials.gov Identifier: NCT00607035    
Other Study ID Numbers: J_Core_071226
J_Core_071226_01
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: November 20, 2008
Last Verified: May 2008
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists