Hypertension
Conditions
Interventions
- Irbesartan 200mg in morning, once daily - Amlodipine 5mg in evening, once daily - Treatment period: 8 weeks
- Irbesartan 200mg in morning, once daily - Efonidipine 40mg in evening, once daily -
Sponsors
J-HOME-ALB study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) More than 35 years of age 2) Patient with essential hypertension, who has never been treated or has not treated within four weeks 3) Patient with average home mornig systolic blood pressure >= 135mmHg 4) Patient with spot urinary albumin / creatinine ratio >= 10 mg/g creatinine and <= 299 mg/g creatinine 5) Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study 6) Patient with average home mornig systolic blood pressure >= 125mmHg after receving monotherapy with irbesartan 200mg for four weeks in addition to four-week monothrapy with irbesartan 100mg
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to components of compounds of irbesartan, amlodipine, efonidipine, or trichlormethiazide 2) Past history of major cardiac events or intervention (e.g., myocardial infarction, stroke) within 6 months prior to the start of the study. 3) Secondary hypertension other than renal hypertension 4) Casual or home blood pressure >= 180 / 110 mgHG 5) Patient with severe renal disease (serum creatinine >=2.0 mg/dL), acute renal failure, hyponatremia, or hypokalemia 6) Severe hepatic disease (ALT >= 100 IU/L) 7) Cardiac failure (above NYHA grade II) 8) Cancer or poor-prognosis diseases 9) Uncontrolled diabetes mellitus (HbA1c >= 8%) 10) Pregnancy or breast feeding, or a female expecting to conceive within the study 11) Patient ineligible to this study due to other medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of efficacy on change of early morning urinary albumin / creatinine ratio among three groups treated for eight weeks with amlodipine, efonidipine, or trichlormethiazide in hypertensive patients with positive spot urinary microalbumin whose blood pressure values underreach target blood pressure level after treatment with irbesartan | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Efficacy of eight-week irbesartan monotherapy on home blood pressure, home hear rate, casual blood pressure, casual heart rate, urinary albumin / creatinine ratio, and laboratory test results including blood, urine, and physiological tests 2) Efficacy of eight-week therapy with amlodipine, efonidipine, or trichlormethiazide in addition to irbesartan on home blood pressure, home hear rate, casual blood pressure, casual heart rate, urinary albumin / creatinine ratio, and laboratory test results including blood, urine, and physiological tests 3) Efficacy of eight-week therapy with amlodipine, efonidipine, or trichlormethiazide in addition to irbesartan on change of electrocardiogram 4) Incidents of side effects, especially edema 5) Incidents of complications | — |
Countries
Japan
Contacts
Public ContactYutaka Imai
Tohoku University Graduate School Department of Planning for Drug Development and Clinical Evaluation
Outcome results
None listed