Hypertension
Conditions
Interventions
Twenty mg/day of olmesartan medoxomil is given instead of pre-administered ARB. Duration of the treatment is 12-14 weeks. Olmesartan medoxomil can be arranged up to maximum dose (40mg/day) until offic
Sponsors
Division of Molecular Cardiovascular Metabolism, University of Tokyo School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Essential hypertensive patients with early morning BP>135/85 mmHg or office BP>140/90 mmHg, who visit outpatient clinic. * Early morning BP is average of all self-measured BP values at early morning (3-5 times/day for 5 continuous days before outpatient visit) (2) Standard dose of ARB other than olmesartan medoxomil and azilsartan for more than 8 weeks before registration. (3) Age is 20 years-old or more and lower than 85 years-old. (4) Patients who can do self-measurement of BP more than 3 times/chance at early morning.. (5) Written informed content is obtained after the explanation of the study is done orally and with written document.
Exclusion criteria
Exclusion criteria: (1) Office systolic BP>180 mmHg or diastolic BP>110mmHg.. (2) Administration of angiotensin converting enzyme (ACE) inhibitor, renin inhibitor, aldosteorone antagonist, diuretic (thiazide, loop, and so on) within 3 months. (3) Decrease in left ventricular function (left ventricular ejection rate<30%) (4) Coexisting atrial fibrillation. (5) Necessity of percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting. (6) Coexisting congenital heart disease. (7) Symptomatic heart failure, acute myocardial infarction, unstable angina, PTCA, and coronary artery bypass grafting 6 months before the start of the present trial. (8) Percutaneous transluminal angioplasty or bypass grafting of peripheral artery 6 months before the present trial. (9) Cerebrovascular disease 6 months before the present trial. (10) Serum Cr>1.5 mg/dL. (11) Coexisting liver injury (AST or ALT>100 IU/L). (12) Coexisting fundus bleeding or papilledema with hypertensive retinopathy. (13) Uncontrollable diabetes mellitus (hemoglobin A1c>8.0%). (14) Hyperpotassemia (serum K>5.5 mEq/L). (15) Pregnancy or possibility of pregnancy. (16) Severe adverse events due to ARB. (17) Participation of the other clinical trial within 6 months before the present trial. (18) Ineligible patients for the present trial according to the judgment by primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of early morning BP with the treatment of olmesartan medoxomil or azilsartan, for 12 to 14 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Absolute value of early morning BP after 12-14 weeks treatments. Percentage of patients with early morning BP reduction (systolic BP>20mmHg, diastolic BP>10mmHg, or mean BP>23mmHg) with 12-14 weeks treatments. Influence of 12-14 weeks treatments on the below parameters: (2) Standard deviation of early morning BP. (3) Twenty-four hours ambulatory BP measurent (if possible) (4) Office BP (5) Serum Na, K, and urine Na, K, creatinine (Cr) (6) Serum Cr, estimated glomerular filtration rate (eGFR). And staging of chronic kidney disease (CKD) with eGFR. (7) Serum uric acid (8) Urine protein/Cr ratio and staging of urine protein/Cr ratio. (9) Adverse events and severe adverse events | — |
Countries
Japan
Contacts
Public ContactAndo, Katsuayuki
University of Tokyo School of Medicine Division of Molecular Cardiovascular Metabolism
Outcome results
None listed