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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000137
Receipt No. 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

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Basic information
Public title Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) Study: Prospective Randomized Open-label Blinded Endpoint (PROBE)
Acronym HOMED-BP Study
Scientific Title Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) Study: Prospective Randomized Open-label Blinded Endpoint (PROBE)
Scientific Title:Acronym HOMED-BP Study
Region
Japan

Condition
Condition Untreated essential hypertensive patients
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 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
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The composite of non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death.
Key secondary outcomes Cerebrovascular disease, coronary heart disease, heart failure, renal failure, peripheral vascular disease, cancer, pneumonia, occurrence of new diabetes and mortality by all causes.

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Less intensive group (Home BP value 125/85-134/84 mmHg)
and
any angiotensin II receptor blockers as a first-line drug.
Interventions/Control_2 Less intensive group (Home BP value 125/85-134/84 mmHg)
and
any angiotensin converting enzyme inhibitors as a first-line drug.
Interventions/Control_3 Less intensive group (Home BP value 125/85-134/84 mmHg)
and
any calcium channel blockers as a first-line drug.
Interventions/Control_4 More intensive group (Home BP value under 125/85 mmHg)
and
any angiotensin II receptor blockers as a first-line drug.
Interventions/Control_5 More intensive group (Home BP value under 125/85 mmHg)
and
any angiotensin converting enzyme inhibitors as a first-line drug.
Interventions/Control_6 More intensive group (Home BP value under 125/85 mmHg)
and
any calcium channel blockers as a first-line drug.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Home systolic BP value >= 135 and/ or diastolic BP >= 85 mmHg without antihypertensive medication.
Key exclusion criteria 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.
Target sample size 9000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Imai
Organization Tohoku University Graduate School of Pharmaceutical Sciences and Medicine
Division name Planning for Drug Development and Clinical Evaluation
Zip code
Address 2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575, Japan
TEL 022-717-7770
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kei Asayama
Organization HOMED-BP Secretariat
Division name Secretariat
Zip code
Address 2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575, Japan
TEL 022-717-7775
Homepage URL http://www.cpt.med.tohoku.ac.jp/HOMED-BP/index.html
Email homedbp@mail.tains.tohoku.ac.jp

Sponsor
Institute HOMED-BP Study Group
Institute
Department

Funding Source
Organization Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 09 Day

Related information
URL releasing protocol http://www.cpt.med.tohoku.ac.jp/HOMED-BP/index.html
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2000 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2001 Year 05 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information 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.

Management information
Registered date
2005 Year 09 Month 08 Day
Last modified on
2010 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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