Hypertension Control Based on Home Blood Pressure

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00198562
• Other study ID #: H16-CV-001
• Secondary ID: 200400510B
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: April 18, 2008
• Start date: April 2000
• Est. completion date: March 2012

Study information

• Verified date: April 2008
• Source: Ministry of Health, Labour and Welfare, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2600
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Amlodipine, Losartan
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years

Locations

Country	Name	City	State
Japan	National Cardiovascular Center	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Labour and Welfare, Japan	Japan Cardiovascular Research Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined cardiovascular events		5 years	No
Secondary	Total mortality		5 years	Yes
Secondary	Cardiovascular mortality		5 years	No
Secondary	Myocardial infarction and new-onset angina		5 years	No
Secondary	Stroke and transient ischemic attack		5 years	No
Secondary	Renal failure		5 years	No
Secondary	Aortic and peripheral artery diseases		5 years	No
Secondary	Left ventricular mass and function		5 years	No
Secondary	Urinary albumin and renal function		5 years	No