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Hypertension Control Based on Home Blood Pressure

NCT ID: NCT00198562

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2012-03-31

Brief Summary

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The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.

The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (morning home BP \<140 mmHg) or (2) strict control group (morning home BP \<130 mmHg), and to (a) amlodipine group or (b) losartan group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. The participants will be followed up for 5 years.

Detailed Description

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The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.

The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. Inclusion criteria are 40-79 years old treated or untreated hypertensive patients without serious medical conditions. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (target morning home BP \<140 mmHg) or (2) strict control group (morning home BP \<130 mmHg), and to (a) amlodipine group (2.5-5 mg od) or (b) losartan group (25-50 mg od). Additional antihypertensive drugs (diuretics, beta-blockers and alpha-blockers) can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. Primary end point is combined cardiovascular events.The participants will be followed up for 5 years.

Conditions

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Hypertension

Keywords

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Antihypertensive therapy Home blood pressure Systolic blood pressure Morning blood pressure Calcium antagonist Angiotensin receptor antagonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)

Group Type ACTIVE_COMPARATOR

Amlodipine, Losartan

Intervention Type DRUG

amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years

2

antihypertensive drug (amlodipine vs losartan)

Group Type ACTIVE_COMPARATOR

Amlodipine, Losartan

Intervention Type DRUG

amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years

Interventions

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Amlodipine, Losartan

amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years

Intervention Type DRUG

Other Intervention Names

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other antihypertensive drugs (if required)

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of hypertension

Exclusion Criteria

* Severe hypertension (treated with 3 or more antihypertensive drugs)
* Unable to change antihypertensive drugs to a calcium antagonist or an angiotensin antagonist
* Serious medical conditions
* Women who may become to be pregnant
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Cardiovascular Research Foundation

OTHER

Sponsor Role collaborator

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role lead

Responsible Party

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National Cardiovascular Center

Principal Investigators

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Yuhei Kawano, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Hypertension and Nephrology, National Cardiovascular Center

Locations

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National Cardiovascular Center

Suita, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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200400510B

Identifier Type: -

Identifier Source: secondary_id

H16-CV-001

Identifier Type: -

Identifier Source: org_study_id