Unique ID issued by UMIN | C000000137 |
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Receipt number | R000000037 |
Scientific Title | Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) Study: Prospective Randomized Open-label Blinded Endpoint (PROBE) |
Date of disclosure of the study information | 2005/09/09 |
Last modified on | 2010/09/09 17:57:24 |
Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) Study: Prospective Randomized Open-label Blinded Endpoint (PROBE)
HOMED-BP Study
Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) Study: Prospective Randomized Open-label Blinded Endpoint (PROBE)
HOMED-BP Study
Japan |
Untreated essential hypertensive patients
Medicine in general | Cardiology |
Others
YES
To establish the evidence of hypertension treatment for Japanese by Japanese, for Asian by Asian.
1. To examine the association based on home BP between:
a. goal BP level and prognosis
b. goal BP level and regression of the target organ damage
2. To determine the optimal target BP level and the optimal antihypertensive medication
3. To compare the prognosis as well as the regression of the target organ damage among three major antihypertensive drugs (Ca-A, ACE-I and ARB)
4. To examine a possible role of IT for the large-scale intervention study
Efficacy
Confirmatory
Pragmatic
Phase IV
The composite of non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death.
Cerebrovascular disease, coronary heart disease, heart failure, renal failure, peripheral vascular disease, cancer, pneumonia, occurrence of new diabetes and mortality by all causes.
Interventional
Factorial
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
6
Treatment
Medicine | Device,equipment |
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.
40 | years-old | <= |
80 | years-old | > |
Male and Female
Home systolic BP value >= 135 and/ or diastolic BP >= 85 mmHg without antihypertensive medication.
Severe 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.
9000
1st name | |
Middle name | |
Last name | Yutaka Imai |
Tohoku University Graduate School of Pharmaceutical Sciences and Medicine
Planning for Drug Development and Clinical Evaluation
2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575, Japan
022-717-7770
1st name | |
Middle name | |
Last name | Kei Asayama |
HOMED-BP Secretariat
Secretariat
2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575, Japan
022-717-7775
http://www.cpt.med.tohoku.ac.jp/HOMED-BP/index.html
homedbp@mail.tains.tohoku.ac.jp
HOMED-BP Study Group
Japan Cardiovascular Research Foundation
Non profit foundation
Japan
NO
2005 | Year | 09 | Month | 09 | Day |
http://www.cpt.med.tohoku.ac.jp/HOMED-BP/index.html
Unpublished
Completed
2000 | Year | 07 | Month | 24 | Day |
2001 | Year | 05 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
1) Hosohata K, Saito S, Asayama K, Ohkubo T, Kikuya M, Metoki H, Obara T, Kato T, Hashimoto J, Totsune K, Miura Y, Imai Y, The HOMED-BP Study Group. Progress report on The Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) study: status at February 2004. Clin Exp Hypertens. 2007; 29: 69-81.
2) Saito S, Asayama K, Ohkubo T, Kikuya M, Metoki H, Obara T, Hashimoto J, Totsune K, Miura Y, Imai Y; HOMED-BP Study Group. The second progress report on the Hypertension Objective treatment based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) study. Blood Press Monit. 2004; 9: 243-7.
3) Aoki Y, Asayama K, Ohkubo T, Nishimura T, Kikuya M, Metoki H, Hozawa A, Hashimoto J, Michimata M, Matsubara M, Araki T, Imai Y; HOMED-BP Study Group. Progress report on the HOMED-BP Study: hypertension objective treatment based on measurement by electrical devices of blood pressure study. Clin Exp Hypertens. 2004; 26: 119-27.
4) Fujiwara T, Matsubara M, Ohkubo T, Imai Y. Study design of HOMED-BP: hypertension objective treatment based on measurement by electrical devices of blood pressure. Clin Exp Hypertens. 2003; 25: 143-4.
5) Fujiwara T, Nishimura T, Ohkuko T, Imai Y; On behalf of The HOMED-BP Study Group. Rationale and design of HOMED-BP Study: hypertension objective treatment based on measurement by electrical devices of blood pressure study. Blood Press Monit. 2002; 7: 77-82.
2005 | Year | 09 | Month | 08 | Day |
2010 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000037
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