Hypertension Control Based on Home Blood Pressure - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	Related Studies

Hypertension Control Based on Home Blood Pressure

This study is ongoing, but not recruiting participants.
Information provided by Ministry of Health, Labour and Welfare

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Hypertension Control Based on Home Blood Pressure

Official Title ^†

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

Brief Summary

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

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 Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Combined cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Total mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Cardiovascular mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Myocardial infarction and new-onset angina [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Stroke and transient ischemic attack [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Renal failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Aortic and peripheral artery diseases [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Left ventricular mass and function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Urinary albumin and renal function [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Condition ^†

Hypertension

Intervention ^†

Drug: Amlodipine, Losartan

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

2600

Start Date ^†

April 2000

Completion Date

March 2012

Eligibility Criteria ^†

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

Gender

Both

Ages

40 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Administrative Information Fields

NCT ID ^†

NCT00198562

Organization ID

H16-CV-001

Secondary IDs ^††

200400510B

Study Sponsor ^†

Ministry of Health, Labour and Welfare

Collaborators ^††

Japan Cardiovascular Research Foundation

Investigators ^†

Principal Investigator:

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

Division of Hypertension and Nephrology, National Cardiovascular Center

Information Provided By

Ministry of Health, Labour and Welfare

Verification Date

April 2008

First Received Date ^†

September 12, 2005

Last Updated Date

April 18, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.