UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000137
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

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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 or person

Institute

HOMED-BP Study Group

Institute

Department

Personal name



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

Value
https://center6.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