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

Not Applicable

Terminated

Conditions: 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

Registration Number: JPRN-UMIN000015378

Lead Sponsor: SHIONOGI & CO., LTD.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Terminated

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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