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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002071
Receipt No. R000002525
Scientific Title Study on usefulness evaluation of aggressive antihypertensive therapy using ambulatory blood pressure measurement (ABPM)
Date of disclosure of the study information 2009/06/12
Last modified on 2009/06/12

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Basic information
Public title Study on usefulness evaluation of aggressive antihypertensive therapy using ambulatory blood pressure measurement (ABPM)
Acronym INBA Study
(Investigation for Normalized Blood pressure control with Appropriate medication)
Scientific Title Study on usefulness evaluation of aggressive antihypertensive therapy using ambulatory blood pressure measurement (ABPM)
Scientific Title:Acronym INBA Study
(Investigation for Normalized Blood pressure control with Appropriate medication)
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 As a part of intensive medical treatment based on the guideline for treatment of hypertension, a combination drug of an angiotensin II receptor antagonist (losartan 50 mg) and a low-dose diuretic (HCTZ12.5 mg) is to be administered in patients with uncontrolled hypertension, and its effects on diurnal blood pressure variation and function/form of the heart are to be examined. Furthermore, safety of this medical approach is also to be examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change and % change in ambulatory blood pressure measurement (ABPM) after 12weeks of treatment
Key secondary outcomes - Change and % change in ABPM after 24 and 48 weeks of treatment
- Effect on regression of heart hypertrophy, left ventricular mass index, augmentation index, and laboratory markers (MMP2, MMP9, TIMP, BNP) after 48 weeks of treatment
- Change in office blood pressure after 12, 24 and 48 weeks of treatment
- Safety throughout the treatment period
- Exploratory subgroup analysis

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria:
1) Patients with essential hypertension, who have been previously treated with antihypertensive drugs including ARB for more than 4 weeks, however, the target blood pressure defined by the guideline for treatment of hypertension has not been achieved
2) Men and women aged 20 to 80 years at the time of the first visit
3) Outpatients
4) Patients who fully understand the study procedures and have given written informed consent to participate in the study
Key exclusion criteria Exclusion criteria:
1) Patients under treatment with diuretics
2) Patients with uncontrolled hypertension (diastolic blood pressure &#8805;110mmHg)
3) Patients with malignant hypertension
4) Patients with cardiac failure (NYHA grade III or IV)
5) Patients with a previous history of gout attack or uncontrolled hyperuricemia (&#8805;8.0mg/dL)
6) Patients who have stroke, AMI and/or critical vascular complications that required hospitalization within 6 months prior to the intervention
7) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period
8) Patients with severe liver dysfunction
9) Patients with renal failure (serum creatinine &#8805;2.0 mg/dL)
10) Patients with a history of hypersensitivity to ingredients of losartan / HCTZ
11) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
12) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Seno
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Internal medicine
Zip code
Address 1715 Kamakari, Inba-mura, Inba-gun, Chiba
TEL 0476-99-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chikao Ibuki
Organization Hokuso hypertension study group secretariat
Division name Hokuso hypertension study group secretariat
Zip code
Address
TEL
Homepage URL
Email ibuki@nms.ac.jp

Sponsor
Institute Hokuso hypertension study group
Institute
Department

Funding Source
Organization Osaka geriatric-diseases prevention association
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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
2009 Year 06 Month 12 Day

Related information
URL releasing protocol
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
Date of protocol fixation
2007 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2009 Year 06 Month 12 Day
Last modified on
2009 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002525

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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