comparison of Therapy with Olmesartan medoxomil monotherapy or azelnidipine and olmesartan medoxomil combination in hypertensive patients with chronic KIdney disease
- Conditions
- Hypertensive patients with CKD under the treatment of the angiotensin receptor blocker(ARB), olmesartan medoxomil 20mg/day
- Registration Number
- JPRN-UMIN000004489
- Lead Sponsor
- iigata University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Secondary hypertension or malignant hypertension (within hypertension in level 3) 2) Severe heart failure (NYHA Class is equal or more than III) 3) Atrial fibrillation or flutter with severe arrhythmia 4) Severe renal failure or liver failure (patient on dialysis, AST or ALT is more than 5 times higher upper limits) 5) Not appropriate for change to the test drugs from current therapy for coronary disease (i.e. CCB, diuretics, etc.) 6) Patient with severe adverse effects by RAS inhibitor, CCB and diuretic 7) Patient has merged the disease seems to be bad, such as malignant tumor prognosis. 8) Type 1 diabetes and type 2 diabetes required hospitalization due to high hemoglobin A1c (equal and more than 9.0%), extremely high blood glucose, or diabetic ketoacidosis. 9) Patients already used other CCB or a diuretic. 10) Pregnant, possible to be pregnant, or willing to be pregnant 11) Patients who are inadequate by determination of physician in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in urinary albumin/creatinine(Alb/Cr) ratio in early morning samples from pretreatment period to 12 months of treatment
- Secondary Outcome Measures
Name Time Method 1. blood pressure(Office,Home) 2. Pulse rate(Home) 3. Change in the urinary Alb/Cr ratio 4. Change in eGFR 5. Relationship between BMI and BP/urinary Alb/Cr ratio 6. Change in HbA1c levels 7. Change in urinary excretion of sodium 8. Change in serum uric acid 9. Change in urinary megalin and urinary podocalyxin 10. Cerebro-cardio-vascular events