NCT00607035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 20, 2008

Status Verified

May 1, 2008

Enrollment Period

1.9 years

First QC Date

December 26, 2007

Last Update Submit

November 19, 2008

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Changes in central BP and ambulatory BP

    6 months

Secondary Outcomes (2)

  • Changes in office BP and home BP.

    6 months

  • Changes in hypertensive target organ damage. Clinical laboratory data.

    6 months

Study Arms (2)

A

EXPERIMENTAL

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

H

EXPERIMENTAL

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

Interventions

Olmesartan medoxomil ＋AzelnidipineDRUG

The ARB plus CCB combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day for 6 months.

Also known as: arm A
A
Olmesartan medoxomil + HydrochlorothiazideDRUG

The ARB plus Diuretics combination therapy group is administered olmesartan medoxomil 20mg/day and hydrochlorothiazide 12.5mg/day for 6 months.

Also known as: arm H
H

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jichi Medical University School of Medicine

Tochigi, Japan

Location

Related Publications (3)

  • Matsui Y, O'Rourke MF, Hoshide S, Ishikawa J, Shimada K, Kario K. Combined effect of angiotensin II receptor blocker and either a calcium channel blocker or diuretic on day-by-day variability of home blood pressure: the Japan Combined Treatment With Olmesartan and a Calcium-Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study. Hypertension. 2012 Jun;59(6):1132-8. doi: 10.1161/HYPERTENSIONAHA.111.189217. Epub 2012 Apr 30.

    PMID: 22547439DERIVED

  • Matsui Y, Eguchi K, O'Rourke MF, Ishikawa J, Shimada K, Kario K. Association between aldosterone induced by antihypertensive medication and arterial stiffness reduction: the J-CORE study. Atherosclerosis. 2011 Mar;215(1):184-8. doi: 10.1016/j.atherosclerosis.2010.12.022. Epub 2010 Dec 30.

    PMID: 21241987DERIVED

  • Matsui Y, Eguchi K, O'Rourke MF, Ishikawa J, Miyashita H, Shimada K, Kario K. Differential effects between a calcium channel blocker and a diuretic when used in combination with angiotensin II receptor blocker on central aortic pressure in hypertensive patients. Hypertension. 2009 Oct;54(4):716-23. doi: 10.1161/HYPERTENSIONAHA.109.131466. Epub 2009 Aug 10.

    PMID: 19667251DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Olmesartan MedoxomilHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kazuomi Kario

    Jichi Medical University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

February 5, 2008

Study Start

May 1, 2006

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

November 20, 2008

Record last verified: 2008-05

Locations

JP(1)