UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015378
Receipt number R000017859
Scientific Title Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure
Date of disclosure of the study information 2014/10/09
Last modified on 2015/09/18 10:50:38

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Basic information

Public title

Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure

Acronym

Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure

Scientific Title

Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure

Scientific Title:Acronym

Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure

Region

Japan


Condition

Condition

Hypertensive patients without any treatment or those whose blood pressure can not be controlled within the targeted level recommended by JSH2014 guideline by other ARB at conventional dose except one treated in this study

Classification by specialty

Medicine in general Cardiology Nephrology
Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet changed from Irbesartan100mg single tablet on circadian rhythm of blood pressure and the average of nocturnal blood pressure by the use of ABPM and measurement at home

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Circadian disparity of homed blood pressure at wake-up and while sleeping after the change to Irbesartan100mg/Trichlormethiazide1mg combination tablet from Irbesartan100mg single tablet

Key secondary outcomes

The changes to Irbesartan100mg/Trichlormethiazide1mg combination tablet from Irbesartan100mg single tablet:
・Homed blood pressure at wake-up and before sleeping
・Average of nocturnal blood pressure in each group divided by the type of circadian rhythm
・Achievement rate to the targeted level of hypotension recommended by JSH2014GL
・ACR in DM patients
・BNP
・Urate
・Salt excretion
・Other clinical examinations


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients who shall be orally administered Irbesartan 100 mg Tablets once a day in the morning shall be followed-up for 8 weeks.
The studies in the patients whose clinical blood pressure after 8 weeks would be lower than 120/70 mmHg shall be discontinued.
In other patients, the antihypertensive drug shall be changed to Irbesartan 100 mg/trichlormethiazide 1 mg Combination Tablets administered once a day in the morning, and whose blood pressure shall be determined by ABPM for a further 12 weeks.

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

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who we could acquire their consents with document from the free willness for the participation in this study
2) Age: older than 30 years
3) Gender: no object
4) Out-patients
5) Patients whose blood pressure could not be achieved to the targeted level of the blood pressure at office recommended by JSH2014GL
6) Patients with concept 5) who also have any risk factor among diabetes, CKD or obese
7) Patients who can receive the prescription designed during study period

Key exclusion criteria

1)Patients with the history of hypersensitivity to study drug
2)Patients with pregnancy or possibilities
3)Patients with hyperkalemia(serum K>5.5Eq)
4)Patients with acute renal failure
5)Patients with dialysis therapy or renal implantation
6)Patients with the history of ischemic heart disease or stroke within 6 months
7)Patients with condition severer than NYHA classII-M
8)Patients with severe renal failure(SCr>= 2.0mg/dL)
9)Patients with severe concomitant disease as a malignant tumor or limited life expectancy (but except the patients who have not been received any treatment for malignant cancer for more than 5 years before the day of consent acquisition)
10)Patients with poor control of blood pressure(SBP>= 120mmHg or DBP>= 200mmHg or urgent hypertension
11)Patients with serum Na(<135mEq/L) and/or K(<3.5mEq/L)
12)Patients with sleep apnea syndrome
13)Patients with the therapy for hypertention with Irbesartan within three months in past
14)Patients treated with antihypertensive agents except ARBs within three months in past
15)Patients with malignant failure in bile secretion or severe hepatic impairment
16)Patients who are judged inadequate to participate by doctor

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuro Yoshida

Organization

ONGA NAKAMA Medical Association ONGA Hospital

Division name

Department of Cardiology

Zip code


Address

1725-2, ooaza-Ozaki,Onga-cho,Onga-gun,Fukuoka,Tokyo,Japan

TEL

093-281-2810

Email

tetsuro-moet@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Azusa Kaneko

Organization

Satt Co., Ltd.

Division name

Clinical study promotion group

Zip code


Address

2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-5312-5026

Homepage URL


Email

restore@sa-tt.co.jp


Sponsor or person

Institute

SHIONOGI & CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

SHIONOGI & CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

遠賀中間医師会 おんが病院


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 09 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

Terminated

Date of protocol fixation

2014 Year 08 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 12 Day

Last follow-up date

2015 Year 09 Month 03 Day

Date of closure to data entry

2015 Year 09 Month 30 Day

Date trial data considered complete

2015 Year 09 Month 30 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 09 Day

Last modified on

2015 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017859


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name