Hypertension
Conditions
Interventions
Arm A receives valsartan/amlodipine combination once daily in the morning for 8 weeks, after that switches to before bedtime dose for 8 weeks.
Arm B receives valsartan/amlodipine combination once dail
Sponsors
Division of Cardiovascular Medicine Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypertensive patients with an average clinic systolic blood pressure (SBP) of 140 mmHg or higher or diastolic blood pressure (DBP) of 90 mmHg or higher on at least medicated by CCB or ARB standard or maximum dose for 4 weeks or more.
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity to test drug or dihydropyridine compounds. 2) Patients being treated concomitantly with hypertensive drugs other than ARB or CCB 3) Secondary hypertension or malignant hypertension. 4) Severe heart failure (New York Heart Association (NYHA) functional class III or more). 5) Severe kidney disease with serum creatinine level 3.0mg/dL or higher, or on dialysis 6) Severe liver and biliary system disorders. 7) History of cardiovascular (myocardial infarction) or cerebrovascular (cerebral infarction) event 8) Patients with endocrine disease. 9) Patients with malignant neoplasms 10) Pregnant or women of child bearing potential 11) Patients who is not given informed consent by themselves 12) Patients decided inappropriate subjects for this study by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sleep blood pressure evaluated by ABPM before and after ARB/CCB combination dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in clinic BP or pulse rate before and after ARB/CCB combination dosing; target BP achieving level. 2. Change in daytime (waking hour) BP, morning BP, morning surge and BP variability (SD) assessed by ABPM. 3. Change in ambulatory central BP, augmentation index, cardiac output, total peripheral vascular resistance, pulse wave velocity before and after ARB/CCB combination dosing. 4. Change in home BP, pulse rate, diurnal variation of BP, differences in morning and evening blood pressure before and after ARB/CCB combination dosing. 5. Change in the effects on cardiac function (NT -pro BNP, high-sensitive [hs] cardiac troponin T [hs-cTnT]) before and after ARB/CCB combination dosing. 6. Change in the effects on anti-inflammatory effects before and after ARB/CCB combination dosing. 7. Change in the effects on renal function (urinary albumin excretion rate) before and after ARB/CCB combination dosing. 8. To evaluate the safety of test drug (e.g., adverse events) other than primary outcome. | — |
Countries
Japan
Contacts
Public ContactSatoshi Hoshide
Jichi Medical University Division of Cardiovascular Medicine
Outcome results
None listed