Hypertension
Conditions
Sponsors
Study group for vascular protection
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients with essential hypertension, who have been previously treated with monotherapy of an RAS blocker for 4 weeks or more, however, the target blood pressure defined by the guideline for treatment of hypertension has not been achieved 2) Outpatients aged 30 to 75 years at the time of the first visit 3) Patients who fully understand the study procedures and have given written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Patients with overt nephropathy (microalbuminuria more than 300 mg/g Cr) 2) Patients with uncontrolled hypertension (systolic blood pressure more than 180mmHg or diastolic blood pressure more than 110mmHg at the time of informed consent) 3) Patients with malignant hypertension 4) Patients with secondary hypertension 5) Patients with liver dysfunction (ALT or AST over three times the normal value) 6) Patients with a previous history of gout attack 7) Patients who have critical cardiovascular complications that required hospitalization within 6 months prior to informed consent 8) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 9) Patients with cardiac insufficiency (above NYHA grade III) 10) Patients with uncontrolled arrhythmia 11) Patients under treatment with diuretics 12) Patients with a history of hypersensitivity to ingredients of the study drugs 13) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in microalbuminuria after 48 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change and % change in flow-mediated vasodilatation (FMD) and cardio ankle vascular index (CAVI) after 48 weeks of treatment [only in patients with microalbuminuria (8-299 mg/g Cr) during the observation period] - Change and %change in microalbuminuria (excludin change after 48 weeks of treatment), uric acid in urine, Na in urine, eGFR, hs-CRP, BNP, serum uric acid, Na, K, Cl, P after 12 and 48 weeks of treatment - Change and % ahange in L-FABP in urine, 8OHdG in urine, homocysteine, plasma ADMA after 12 and 48 weeks of treatment [only in patients with microalbuminuria (8-299 mg/g Cr) during the observation period] -Change and %change in office/causual blood pressure after 12, 24, 36 and 48 weeks of treatment -Cost of antihypertensive ddrug used during the study period -Safety throughout the study period | — |
Countries
Japan
Contacts
Public ContactNorio Komai
Study group for vascular protection secretariat Study group for vascular protection secretariat
Outcome results
None listed