Hypertension
Conditions
Interventions
Change from olmesartan medoxomil 20mg/day or azelnidipine 16mg/day to coadministration of olmesartan medoxomil 20mg and azelnidipine 16mg per day for a period of 16 weeks
Sponsors
Department of Nephrology and Hypertension, Kawasaki Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Hypertensive outpatients whose blood pressures show more than 135/85mmHg for the latest period of five consecutive days despite the administration of 16mg/day azelnidipine or 20mg/day olmesartan medoxomil for a period of more than four weeks 2) Patients who are able to measure home blood pressure on their own upper arms and to write the values down in the recording notebook 3) Patients with the informed consent to this study
Exclusion criteria
Exclusion criteria: 1) Patients with the past history of hypersensitivity to test drugs, other ARBs or dihydropyridine CCBs 2) Female in current or expected pregnancy 3) Patients with the past history of cerebro-cardiovascular diseases within six months 4) Patients whose blood pressures show more than 180/110mmHg 5) Patients receiving the dialysis therapy or with severe renal dysfunction (eGFR<30ml/min/1.73m2) 6) Patients with severe hepatic dysfunction (showing more than 100 IU/L of AST or ALT) 7) Patients receiving treatment for a malignant neoplasm 8) Patients taking a contraindication drug for coadministration of test drugs 9) Patients judged as unsuitable for participating in this study by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of home blood pressure variability | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change of blood pressure at clinic and home 2) Change of pulse rate at clinic and home 3) Change of cardiac function (double product: pulse rate x systolic blood pressure) 4) Change of renal function (eGFR: estimated glomerular filtration rate) 5) Change of albuminuria 6) Incidence and degree of detrimental events | — |
Countries
Japan
Contacts
Public ContactHajime Nagasu
Kawasaki Medical School Department of Nephrology and Hypertension
Outcome results
None listed