Unique ID issued by UMIN | UMIN000015378 |
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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 |
Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure
Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure
Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure
Effects of Irbesartan100mg/Trichlormethiazide1mg combination tablet on circadian and nocturnal blood pressure
Japan |
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
Medicine in general | Cardiology | Nephrology |
Geriatrics |
Others
NO
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
Efficacy
Circadian disparity of homed blood pressure at wake-up and while sleeping after the change to Irbesartan100mg/Trichlormethiazide1mg combination tablet from Irbesartan100mg single tablet
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
30 | years-old | <= |
Not applicable |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Tetsuro Yoshida |
ONGA NAKAMA Medical Association ONGA Hospital
Department of Cardiology
1725-2, ooaza-Ozaki,Onga-cho,Onga-gun,Fukuoka,Tokyo,Japan
093-281-2810
tetsuro-moet@nifty.com
1st name | |
Middle name | |
Last name | Azusa Kaneko |
Satt Co., Ltd.
Clinical study promotion group
2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
03-5312-5026
restore@sa-tt.co.jp
SHIONOGI & CO., LTD.
SHIONOGI & CO., LTD.
Profit organization
NO
遠賀中間医師会 おんが病院
2014 | Year | 10 | Month | 09 | Day |
Unpublished
Terminated
2014 | Year | 08 | Month | 08 | Day |
2014 | Year | 09 | Month | 12 | Day |
2015 | Year | 09 | Month | 03 | Day |
2015 | Year | 09 | Month | 30 | Day |
2015 | Year | 09 | Month | 30 | Day |
2014 | Year | 10 | Month | 09 | Day |
2015 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017859
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