The Japan-Combined Treatment With Olmesartan and a Calcium Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study (J-CORE)
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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) |
- Changes in central BP and ambulatory BP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- 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 |
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 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 May 23, 2013