Comparative effects on nocturnal hypertension at home by combination therapy of ARB/CCB and ARB/diuretics

Not Applicable

Active, not recruiting

• Conditions: Hypertension

• Registration Number: JPRN-UMIN000016629
• Lead Sponsor: Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine/ SHIONOGI&CO.,LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-25
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: No longer recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

At interim registration:
Patients whose profiles are fulfilled with all of the following criterias will be included.
1) patients who give written consent to participation in the study at their own will
2) at the age of 30 years old or older and younger than 85 years old (at consent acquisition)
3) male or female (except females with possibility of pregnancy)
4) outpatient
5) hypertensive patients

Untreated patients*1 and patients*2 treated with antihypertensive drugs
*1:Patients with office BP >=140mmHg in SBP or 90mmHg in DBP ( home BP >=135mmHg in SBP or 85mmHg in DBP),

*2: Patients treated concomitantly with two drugs among ARB, CCB anddiuretics et al. (including fixed-dose combination drugs with two component) or single drug at doses less than ordinary doses instructed in the package inserts for Japanese

6) The patients who can accept irbesartan, trichlormethiazide and amlodipine

At the official registration
1)The patients whose mean nocturnal blood pressure measured during five days before hospital visiting at week4 are higher than SBP120mmHg or DBP70mmHg

Exclusion Criteria

Patient who concern the following criterias are excluded:
At interim registration:
1)patient in being treated with irbesartan
2) patient with severe kidney dysfunction(serum creatinine >= 2.0 mg/dL )
3) patient with severe liver dysfunction(incliding biliary cirrhosis or cholestasis band)
4) patient with severe heart failure(New York Heart Association(NYHA) functional class >=II M )
5)patient diagnosed the ischemic heart disease or stroke within the past 6 months before consent acquisition
6) patient with history of hypersensitivity to ARB, thiazide drugs ,CCB and these combination drugs
7) patient with hypokalemia(K<3.0mEq/L) or hyperkalemia(K>=5.5mEq/L)
8) patients with malignant tumor or the history of malignant tumor within the past 5 years before consent acquisition)
9) pregnant woman or woman with possibility of being pregnant.
10) patient with sleep apnea syndrome
11) patient with not-well controlled hypertension(SBP>=200mmHg or DBP>=120mmHg at office)
12) patient deemed ineligible by investigator

At official registration
1)patient who is deemed ineligible by investigator from implemental status in monitoring by the use of 3G-enabled BPM with MedicalLINK high blood management service during observation period
2) patient with serious adverse events during the observation period
3) patient deemed ineligible by investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified