search
Back to results

Hypertension Control Based on Home Blood Pressure

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Amlodipine, Losartan
Sponsored by
Ministry of Health, Labour and Welfare, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Antihypertensive therapy, Home blood pressure, Systolic blood pressure, Morning blood pressure, Calcium antagonist, Angiotensin receptor antagonist

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

antihypertensive drug (amlodipine vs losartan)

Outcomes

Primary Outcome Measures

Combined cardiovascular events

Secondary Outcome Measures

Total mortality
Cardiovascular mortality
Myocardial infarction and new-onset angina
Stroke and transient ischemic attack
Renal failure
Aortic and peripheral artery diseases
Left ventricular mass and function
Urinary albumin and renal function

Full Information

First Posted
September 12, 2005
Last Updated
April 18, 2008
Sponsor
Ministry of Health, Labour and Welfare, Japan
Collaborators
Japan Cardiovascular Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00198562
Brief Title
Hypertension Control Based on Home Blood Pressure
Official Title
Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2000 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Labour and Welfare, Japan
Collaborators
Japan Cardiovascular Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Antihypertensive therapy, Home blood pressure, Systolic blood pressure, Morning blood pressure, Calcium antagonist, Angiotensin receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
Arm Title
2
Arm Type
Active Comparator
Arm Description
antihypertensive drug (amlodipine vs losartan)
Intervention Type
Drug
Intervention Name(s)
Amlodipine, Losartan
Other Intervention Name(s)
other antihypertensive drugs (if required)
Intervention Description
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
Primary Outcome Measure Information:
Title
Combined cardiovascular events
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Total mortality
Time Frame
5 years
Title
Cardiovascular mortality
Time Frame
5 years
Title
Myocardial infarction and new-onset angina
Time Frame
5 years
Title
Stroke and transient ischemic attack
Time Frame
5 years
Title
Renal failure
Time Frame
5 years
Title
Aortic and peripheral artery diseases
Time Frame
5 years
Title
Left ventricular mass and function
Time Frame
5 years
Title
Urinary albumin and renal function
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuhei Kawano, M.D., Ph.D.
Organizational Affiliation
Division of Hypertension and Nephrology, National Cardiovascular Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Hypertension Control Based on Home Blood Pressure

We'll reach out to this number within 24 hrs