Japanese evaluation between FormuLa of Azelnidipine and amlodipine add on olmesartan to Get antialbuminuric effect study

UMIN ID: UMIN000001666

Registered date:29/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertensive patients with albuminuria and diabetes (diabetic nephropathy)
• Date of first enrollment: 2009/05/01
• Target sample size: 250
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Azelnidipine (8 to 16 mg/day) is added in patients with olmesartan and target blood pressure (BP) is under 130/80 mmHg,
Amlodipine (2.5 to 5 mg/day) is added in patients with olmesartan and target BP is under 130/80 mmHg

Outcome(s)

• Primary Outcome: Changes in urinary albumin/creatinine (Cr) ratio in spot urine from pretreatment period (average of 2 measured value) to 12 months of treatment
• Secondary Outcome: 1. Percent changes in urinary albumin/Cr ratio from pretreatment period to each period of treatment. Urinary protein/Cr ratio is analyzed similarly to urinary albumin/Cr ratio. 2. Urinary liver-type free fatty acid-binding protein (L-FABP) 3. Urinary 8-hydroxydeoxyguanosine (8-OHdG) 4. Office blood pressure (BP) in outpatient clinic 5. Pulse rate 6. Serum Cr or estimated glomerular filtration rate (eGFR) calculated using the modified MDRD formula in the Japanese Society of Nephrology: eGFR (ml/min/1.73 m2) = 194 x age -0.287 x serum creatinine – 1.094 (multiply by 0.739 in female) 7. Cerebro-cardio-vascular events: cerebro-cardio-vascular mortality (fatal myocardial infarction, fatal heart failure, sudden death, fatal stroke, other cardiovascular death) and hospitalization due to cerebro-cardio-vascular disease (nonfatal myocardial infarction, angina, heart failure, cerebral bleeding, cerebral infarction, transient cerebral ischemic attack)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients who apply any of the flowing cannot participate 1. Hypertensive emergency that requires intravenous administration of antihypertensives 2. Nephritic syndrome (urinary protein >=3.5 g/day and serum total protein <=6.0 g/dL [or serum albumin <=3.0 g/dL]) 3. Adminstration of contraindication drugs (angiotensin converting enzyme [ACE] inhibitor, angiotensin receptor blocker [ARB] other than olmesartan, CCB other than the assigned one, adrenocorticosteriod, immunosuppressant, azole antifungal agent [itraconazole, miconazole, etc.], HIV protease inhibitor [ritonavir, saquinqvir, indinavir, etc]) or long-term (>= 2 weeks) administration of non-steriod anti-inflammatory drugs (NSAID) 4. Past history of severe side effect of CCB, ARB, or ACE inhibitor 5. Cerebrovascular disease occurs within 6 months 6. Sever heart failure (NYHA class >= III), severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyrhythmia with severe tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome with severe bradycardia, atrio-ventricular block with severe bradycardia), myocardial infarction or percutaneous transluminal coronary angioplasty within 6 months 7. Type 1 diabetes and type 2 diabetes required hospitalization due to high hemoglobin A1c (>= 9.0), extremely high blood glucose, or diabetic ketoacidosis 8. AST or ALT is more than 5 times higher upper limits 9. Malignancy 10. Pregnant, possible to be pregnant, or willing to be pregnant 11. Patients who are inadequate by determination of physician in charge

Related Information

• Primary Sponsor: J-FLAG Study Group
• Source(s) of Monetary Support: The Waksman Foundation of Japan Inc.