Overview

This trial is active, not recruiting.

Condition hypertension
Treatment amlodipine, losartan
Phase phase 4
Sponsor Ministry of Health, Labour and Welfare, Japan
Collaborator Japan Cardiovascular Research Foundation
Start date April 2000
End date March 2012
Trial size 2600 participants
Trial identifier NCT00198562, 200400510B, H16-CV-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
amlodipine, losartan other antihypertensive drugs (if required)
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
(Active Comparator)
antihypertensive drug (amlodipine vs losartan)
amlodipine, losartan other antihypertensive drugs (if required)
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years

Primary Outcomes

Measure
Combined cardiovascular events
time frame: 5 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 79 years old.

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

Additional Information

Official title Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
Principal investigator Yuhei Kawano, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2008.
Information provided to ClinicalTrials.gov by Ministry of Health, Labour and Welfare, Japan.