Hypertension
Conditions
Interventions
After 5mg amlodipine monotherapy for 4 weeks run-in period, 150mg aliskiren is added for first 8 weeks, and dose of aliskiren is doubled to 300mg for next 8 weeks.
After 5mg amlodipine monotherapy f
Sponsors
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine.
Fukushima Prefectural Miyashita Hospital Yanai Municipal Heigun Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with clinic or home BP > 140mmHg in systolic and/or > 90mmHg in diastolic (systolic BP > 130mmHg and/or diastolic BP > 85mmHg in case of diabetes), although receiving 5mg amlodipine monotherapy for 4 weeks period or more.
Exclusion criteria
Exclusion criteria: 1) Secondary hypertension 2) Moderate to severe symptom of heart failure (New York Heart Association >class III), fatal arrhythmia 3) A history of stroke, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft within the past 6 months 4) Severe renal dysfunction (eGFR <30ml/min/1.73m2, or serum creatinine >2.0mg/dl) 5) Severe hepatic disease 6) Uncontrolled diabetes (HbA1c >12%) 7) Pregnant women 8) A history of allergy/hypersensitivity to dihydropyridine calcium channel blockers 9) Patients receiving other antihypertensive drugs than amlodipine 10) Patients receiving P-glycoprotein inhibitor 11) Severe dementia 12) Not eligible for this study based on the decision's of a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ambulatory blood pressure monitoring (ABPM) Pulse wave velocity (PWV) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinic BP, home BP, endothelial function (flow-mediated dilatation), plasma renin activity, plasma aldosterone, microalbuminuria, urinary sodium excretion, NT pro-BNP, high-sensitive CRP, high-sensitive troponin-T, cystatin C. | — |
Countries
Japan
Outcome results
None listed