Hypertension with diabetic nephropathy
Conditions
Interventions
amlodipine (initial dose is 5mg/day, but 2.5-10mg is available depending on the effect of blood pressure reduction)
cilnidipine (initial dose is 10mg/day, but 5-20mg is available depending on the bloo
Sponsors
The University of Tokyo Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) urinary albumin-creatinine ratio (mg/g*Cr): 30-300mg/g*Cr (casual urine), 2) serum creatinine: 1.5mg/dl and below, 3) blood pressure (BP): systolic BP (SBP) 130mmHg and above or diastolic BP (DBP) 80mmHg and above, and SBP less than 180mmHg and DBP less than 110mmHg, 4) hemoglobin A1c (HbA1c): HbA1c less than 8.0%, 5) age: from 20 to 75 years old, 6) informed consent, 7) patients who received an antidiabetic therapy for 3 months or more, 8) patients who received an antihypertensive treatment with angiotensin II receptor blockers (ARB) or angiotensin converting enzyme (ACE) inhibitors for 3 months or more, and did not receive calcium channel blockers (CCB) during the most recent 3 months before the enrollment
Exclusion criteria
Exclusion criteria: 1) hypertensive emergency, 2) nephropathy due to other than diabetes, 3) history of severe side effects of a CCB, an ARB or an ACE inhibitor, 4) cerebrovascular disease within 6 months of the start of the trial, 5) severe heart failure (New York heart Association classes III and IV), severe arrhythmia, and myocardial infarction within 6 months of the start of the trial, 6) AST and ALT 5 times and more the upper limit of institution's normal, 7) pregnancy, 8) prior use of corticosteroids, immunosuppresants, or nonsteroidal anti-inflammatory drugs (NAISDs), 9) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urinary albumin-creatinine ratio (mg/g*Cr) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) urinary albumin-creatinine ratio (mg/g*Cr), 2) stage of chronic kidney disease (CKD), 3) serum creatinine level, 4) estimated glomerular filtration rate, 5) cardiovascular event, 6) antihypertensive effect, 7) heart rate, 8) safety parameters | — |
Countries
Japan
Contacts
Public ContactDepartment of EBM Research
Kyoto university Hospital iACT
Outcome results
None listed