Hypertension
Conditions
Interventions
AIMIX(R) combination tablet
Sponsors
Jichi Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria: Patients aged 20 years old and over. Patients who have clinic systolic BP more than or equal to 140/90 mm Hg despite the combination therapy with Calcium antagonist (Amlodipine 5mg) and angiotensin II receptor antagonist (any one of the following drugs: losartan 50mg, valsartan 80mg, candesartan 8mg, telmisartan 40mg, olmesartan 20mg, azilsartan 20mg).
Exclusion criteria
Exclusion criteria: Patients who meet one of the following criteria are excluded: 1) Secondary hypertension 2) Congestive heart failure; onset of acute myocardial infarction in the past 6 month; onset of cerebrovascular disturbance in the past 6 month; current atrial fibrillation or atrioventricular block or severe arrhythmia. 3) hepatic insufficiency (AST or ALT >X2 the upper limit of the normal range) , renal insufficiency (serum Crl.>1.5mg/dL) 4) Diabetic patients being treated with aliskiren. 5) Allergy or drug hypersensitivity. 6) Lack of the informed consent for any reason (e.g. dementia). 7) Women suspected of being pregnant. 8) Patients being ineligible by the attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Target blood pressure reduction rate (clinic blood pressure less than 140/90 mm Hg ). - To document the proportion of extreme-dipper, dipper, non-dipper and riser (diurnal blood pressure variation). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Target blood pressure achievement rate and blood pressure lowering level at the final assessment. - Change in serum creatinine level (e-GFR) and microalbumin level. *eGFR(mL/min/1.73m2) = 194 X Cr -1.094 X age -0.287 X Cr -1.154 (X 0.739 for women) - Change in highly sensitive cardiac troponin T (hs-cTnT), NT-proBNP. | — |
Countries
Japan
Contacts
Public ContactSatoshi Hoshide
Jichi Medical University School of Medicine Division of Cardiovascular Medicine,
Outcome results
None listed