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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015378
Enrollment
30
Registered
2014-10-09
Start date
2014-09-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

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 we

Sponsors

SHIONOGI & CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026