Hypertension Control Based on Home Blood Pressure

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198562

Enrollment

2600

Registered

2005-09-20

Start date

2000-04-30

Completion date

2012-03-31

Last updated

2008-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

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

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.

Interventions

DRUGAmlodipine, Losartan

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame
Combined cardiovascular events	5 years

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026