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

This study has been completed.
Sponsor:
Information provided by:
Jichi Medical University
ClinicalTrials.gov Identifier:
NCT00607035
First received: December 26, 2007
Last updated: November 19, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Hypertension
Drug: Olmesartan medoxomil +Azelnidipine
Drug: Olmesartan medoxomil + Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Jichi Medical University:

Primary Outcome Measures:
  • Changes in central BP and ambulatory BP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in office BP and home BP. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Changes in hypertensive target organ damage. Clinical laboratory data. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: May 2006
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00607035

Locations
Japan
Jichi Medical University School of Medicine
Tochigi, Japan
Sponsors and Collaborators
Jichi Medical University
Investigators
Principal Investigator: Kazuomi Kario Jichi Medical University School of Medicine
  More Information

No publications provided by Jichi Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kazuomi Kario, Jichi Medical University
ClinicalTrials.gov Identifier: NCT00607035     History of Changes
Other Study ID Numbers: J_Core_071226, J_Core_071226_01
Study First Received: December 26, 2007
Last Updated: November 19, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Diuretics
Hydrochlorothiazide
Olmesartan medoxomil
Olmesartan
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 24, 2014