UMIN-CTR Clinical Trial

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

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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 ≥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 (≥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 ≥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

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

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

Institute

Hokuso hypertension study group

Institute

Department

Personal name

Organization

Osaka geriatric-diseases prevention association

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

06

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Prospective observational study

Registered date

2009

Year

06

Month

12

Day

Last modified on

2009

Year

06

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002525