Hypertension
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Outpatients (men and women) aged 20 to 80 years at the time of the first visit 2) Patients with hypertension, who have been previously treated with monotherapy of a standard-dose of ARB for more than 1 month, however, whose blood pressure has not been adequately controlled (systolic blood pressure>=140mmHg and/or diastolic blood pressure>=90mmHg) 3) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Patients with secondary hypertension 2) Patients with uncontrolled hypertension (DBP>=120mmHg) 3) Patients with uncontrolled diabetes (HbA1c>=8.0%) 4) Patients with cardiac insufficiency (over NYHA grade III) 5) Patients with renal failure (serum creatinine>=2.0mg/dl) 6) Patients with liver dysfunction (GOT or GPT>=100IU/L) 7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (UA>=8.0mg/dl) 8) Patients with hyperkalemia (K>=5.5mEq/L) 9) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 10) Patients with a history of hypersensitivity to ingredients of the study drugs 11) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change and % change in left ventricular hypertrophy and left ventricular diastolic function after 48 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change and % change in left ventricular hypertrophy and left ventricular diastolic function after 24 weeks of treatment - Change and % change in blood pressure after 4, 24 and 48 weeks of treatment - Change and % change in BNP, cathecholamine 3 fractionation, hs-CRP, plasma renin activity and aldosterone levels after 24 and 48 weeks of treatment | — |
Countries
Japan
Contacts
Kawasaki Medical School Division of Cardiology