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Hypertension Control Based on Home Blood Pressure

This study is ongoing, but not recruiting participants.
Information provided by Ministry of Health, Labour and Welfare

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Descriptive Information Fields
Brief Title  Hypertension Control Based on Home Blood Pressure
Official Title  Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary Outcome Measure  Combined cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Total mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Cardiovascular mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Myocardial infarction and new-onset angina [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Stroke and transient ischemic attack [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Renal failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Aortic and peripheral artery diseases [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Left ventricular mass and function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Urinary albumin and renal function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Condition  Hypertension
Intervention  Drug: Amlodipine, Losartan
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  2600
Start Date  April 2000
Completion Date March 2012
Eligibility Criteria 

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
Gender Both
Ages 40 Years to 79 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Japan
Administrative Information Fields
NCT ID  NCT00198562
Organization ID H16-CV-001
Secondary IDs †† 200400510B
Study Sponsor  Ministry of Health, Labour and Welfare
Collaborators †† Japan Cardiovascular Research Foundation
Investigators 
Principal Investigator:     Yuhei Kawano, M.D., Ph.D.     Division of Hypertension and Nephrology, National Cardiovascular Center    
Information Provided By Ministry of Health, Labour and Welfare
Verification Date April 2008
First Received Date  September 12, 2005
Last Updated Date April 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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