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UnknownNCT00198562

Hypertension Control Based on Home Blood Pressure

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
2,600 (estimated)
Sponsor
Ministry of Health, Labour and Welfare, Japan · Other Government
Sex
All
Age
40 Years – 79 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAmlodipine, Losartanamlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years

Timeline

Start date
2000-04-01
Primary completion
2012-03-01
Completion
2012-03-01
First posted
2005-09-20
Last updated
2008-04-22

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT00198562. Inclusion in this directory is not an endorsement.