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Hypertension Control Based on Home Blood Pressure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
Japan Cardiovascular Research Foundation
Information provided by:
Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT00198562
First received: September 12, 2005
Last updated: April 18, 2008
Last verified: April 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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

Primary Outcome Measures:
  • Combined cardiovascular events [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Losartan
Amlodipine
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents

ClinicalTrials.gov processed this record on June 28, 2017