Hypertension Control Based on Home Blood Pressure

April 18, 2008 updated by: Ministry of Health, Labour and Welfare, Japan

Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

2600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-8565
        • National Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
Drug: Amlodipine, Losartan
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
Other Names:
  • other antihypertensive drugs (if required)
Active Comparator: 2
antihypertensive drug (amlodipine vs losartan)
Drug: Amlodipine, Losartan
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
Other Names:
  • other antihypertensive drugs (if required)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined cardiovascular events
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular mortality
Time Frame: 5 years
5 years
Total mortality
Time Frame: 5 years
5 years
Myocardial infarction and new-onset angina
Time Frame: 5 years
5 years
Stroke and transient ischemic attack
Time Frame: 5 years
5 years
Renal failure
Time Frame: 5 years
5 years
Aortic and peripheral artery diseases
Time Frame: 5 years
5 years
Left ventricular mass and function
Time Frame: 5 years
5 years
Urinary albumin and renal function
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Labour and Welfare, Japan

Collaborators

Japan Cardiovascular Research Foundation

Investigators

  • Principal Investigator: Yuhei Kawano, M.D., Ph.D., Division of Hypertension and Nephrology, National Cardiovascular Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 18, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H16-CV-001
  • 200400510B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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