Hypertension Control Based on Home Blood Pressure - Full Text View

Sponsor:	Ministry of Health, Labour and Welfare, Japan
Collaborator:	Japan Cardiovascular Research Foundation
Information provided by:	Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:	NCT00198562

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Amlodipine, Losartan	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	2600
Study Start Date:	April 2000
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)	Drug: Amlodipine, Losartan amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years Other Name: other antihypertensive drugs (if required)
Active Comparator: 2 antihypertensive drug (amlodipine vs losartan)	Drug: Amlodipine, Losartan amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years Other Name: other antihypertensive drugs (if required)

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.

Eligibility

Ages Eligible for Study:	40 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198562

Locations

Japan
National Cardiovascular Center
Suita, Osaka, Japan, 565-8565

Sponsors and Collaborators

Ministry of Health, Labour and Welfare, Japan

Japan Cardiovascular Research Foundation

Investigators

Principal Investigator:

Yuhei Kawano, M.D., Ph.D.

Division of Hypertension and Nephrology, National Cardiovascular Center

More Information

No publications provided

Responsible Party:	Yuhei Kawano, M.D., Ph.D., Director of Division of Hypertension and Nephrology, National Cardiovascular Center
ClinicalTrials.gov Identifier:	NCT00198562 History of Changes
Other Study ID Numbers:	H16-CV-001, 200400510B
Study First Received:	September 12, 2005
Last Updated:	April 18, 2008
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ministry of Health, Labour and Welfare, Japan:

Antihypertensive therapy
Home blood pressure
Systolic blood pressure

Morning blood pressure
Calcium antagonist
Angiotensin receptor antagonist

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Amlodipine
Losartan
Angiotensin Receptor Antagonists
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on February 12, 2012