Hypertension Control Based on Home Blood Pressure - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

April 18, 2008

Start Date ^ICMJE

April 2000

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Combined cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Combined cardiovascular events

Change History

Complete list of historical versions of study NCT00198562 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Total mortality
Cardiovascular mortality
Myocardioal infarction and new-onset angina
Stroke and transient ischemic attack
Renal failure
Aortic and peripheral artery diseases
Left ventricular mass and function
Urinary albumin and renal function

Descriptive Information

Brief Title ^ICMJE

Hypertension Control Based on Home Blood Pressure

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Amlodipine, Losartan

Study Arms / Comparison Groups

Active Comparator: target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
Active Comparator: antihypertensive drug (amlodipine vs losartan)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

2600

Estimated Completion Date

March 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00198562

Responsible Party

Yuhei Kawano, M.D., Ph.D., Director of Division of Hypertension and Nephrology, National Cardiovascular Center

Study ID Numbers ^ICMJE

H16-CV-001, 200400510B

Study Sponsor ^ICMJE

Ministry of Health, Labour and Welfare

Collaborators ^ICMJE

Japan Cardiovascular Research Foundation

Investigators ^ICMJE

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, Japan

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP