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Hypertension Control Based on Home Blood Pressure

M

Ministry of Health, Labour and Welfare, Japan

Status and phase

Unknown
Phase 4

Conditions

Hypertension

Treatments

Drug: Amlodipine, Losartan

Study type

Interventional

Funder types

Other

Identifiers

NCT00198562
H16-CV-001
200400510B

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,600 estimated patients

Sex

All

Ages

40 to 79 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

2,600 participants in 2 patient groups

1
Active Comparator group
Description:
target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
Treatment:
Drug: Amlodipine, Losartan
2
Active Comparator group
Description:
antihypertensive drug (amlodipine vs losartan)
Treatment:
Drug: Amlodipine, Losartan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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