NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000137

Registered date:09/09/2005

Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) Study: Prospective Randomized Open-label Blinded Endpoint (PROBE)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUntreated essential hypertensive patients
Date of first enrollment2001/05/01
Target sample size9000
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Less intensive group (Home BP value 125/85-134/84 mmHg) and any angiotensin II receptor blockers as a first-line drug. Less intensive group (Home BP value 125/85-134/84 mmHg) and any angiotensin converting enzyme inhibitors as a first-line drug. Less intensive group (Home BP value 125/85-134/84 mmHg) and any calcium channel blockers as a first-line drug. More intensive group (Home BP value under 125/85 mmHg) and any angiotensin II receptor blockers as a first-line drug. More intensive group (Home BP value under 125/85 mmHg) and any angiotensin converting enzyme inhibitors as a first-line drug. More intensive group (Home BP value under 125/85 mmHg) and any calcium channel blockers as a first-line drug.

Outcome(s)

Primary OutcomeThe composite of non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death.
Secondary OutcomeCerebrovascular disease, coronary heart disease, heart failure, renal failure, peripheral vascular disease, cancer, pneumonia, occurrence of new diabetes and mortality by all causes.

Key inclusion & exclusion criteria

Age minimum40years-old
Age maximum80years-old
GenderMale and Female
Include criteriaHome systolic BP value >= 135 and/ or diastolic BP >= 85 mmHg without antihypertensive medication.
Exclude criteriaSevere hypertension (either Home BP >= 180/120 mmHg or Clinic BP >= 220/125 mmHg), pure systolic hypertension (Home systolic BP >= 135 mmHg and Home diastolic BP =< 65 mmHg), pure diastolic hypertension (Home systolic BP =< 110 mmHg and Home diastolic BP >= 85 mmHg), or contra-indication to treatment with Ca-A, ACE-I, ARB.

Related Information

Contact

public contact
Name Kei Asayama
Address 2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575, Japan Japan
Telephone 022-717-7775
E-mail homedbp@mail.tains.tohoku.ac.jp
Affiliation HOMED-BP Secretariat Secretariat
scientific contact
Name Yutaka Imai
Address 2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575, Japan Japan
Telephone 022-717-7770
E-mail
Affiliation Tohoku University Graduate School of Pharmaceutical Sciences and Medicine Planning for Drug Development and Clinical Evaluation