Hypertension
Conditions
Interventions
(Interventions/ Control 1)
After 4weeks administration of irbesartan100mg/day, the participants are randomly allocated into the group
8 weeks administration of irbesartan100mg/ amlodipine 5mg combination drug
(Interventions/ Control 2)
After 4weeks administration of irbesartan100mg/day, the participants are randomly allocated into
8weeks administration of irbesartan100mg/ trichlormethiazide 1mg combination drug
Sponsors
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine/ SHIONOGI&CO.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in nocturnal systolic blood pressure(SBP) at home from 4 to 12 weeks after study start | — |
Secondary
| Measure | Time frame |
|---|---|
| Parameters for efficacy: Changes of following parameters from 4 to 12 weeks ?noctunrnal diastolic blood pressure (DBP) at home ?waking and bedtime SBP/DBP at home ?SBP/DBP in seated and standing position at office ?interday and circadian variabilities (SD) and pulse pressure of nocturnal, bedtime and waking SBP/DBP at home ?Achievement rate to the targeted hypotensive effects on nocturnal blood pressure at home (SBP<120mmHg and DBP <70mmHg) ?Achievement rate to the targeted BP in seated position at office on JSH2014 guideline ?NT-pro BNP ?urinary micro albumin ?Estimated Na excretion and Na/K ratio in urine Parameters for safety Safety such as adverse events including abnormal values in clinical examinations | — |
Countries
Japan
Outcome results
None listed