The Japan-Combined Treatment With Olmesartan and a Calcium Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study (J-CORE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00607035 |
Recruitment Status :
Completed
First Posted : February 5, 2008
Last Update Posted : November 20, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Olmesartan medoxomil +Azelnidipine Drug: Olmesartan medoxomil + Hydrochlorothiazide | Phase 4 |
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 |

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 |
- Changes in central BP and ambulatory BP [ Time Frame: 6 months ]
- Changes in office BP and home BP. [ Time Frame: 6 months ]
- Changes in hypertensive target organ damage. Clinical laboratory data. [ Time Frame: 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
Japan | |
Jichi Medical University School of Medicine | |
Tochigi, Japan |
Principal Investigator: | Kazuomi Kario | Jichi Medical University School of Medicine |
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 |
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 |