Renoprotective effects of azelnidipine in hypertensive diabetic patients in Mie
Not Applicable
- Conditions
- essential hypertension with type 2 diabetes mellitus and albuminuria
- Registration Number
- JPRN-UMIN000003451
- Lead Sponsor
- Komono Kosei Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 146
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria are: secondary hypertension; history of acute coronary syndrome, heart failure, coronary revascularization, or stroke within the previous 6 months; uncontrolled diabetes mellitus (HbA1c >9.0%); a disorder that requires treatment with calcium channel blockers or diuretics; confirmed or suspected renal artery stenosis; serum creatinine of 2.0mg/dl or more for men and 1.5mg/dl or more for women; pregnant women; or clinic systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the change in the ratio of urine albumin to creatinine (Alb/Cr) from baseline to week 24.
- Secondary Outcome Measures
Name Time Method (1)The change in the urine Alb/Cr ratio from baseline to week 12. (2)The change in estimated glomerular filtration ratio from baseline to week 12 and 24. (3)Proportion of patients who progress to overt diabetic nephropathy (4)The magnitude of albuminuria (5)The changes in serum creatinine, potassium, sodium, LDL-cholesterol, HDL-cholesterol, and HbA1c levels (6)The changes in urine excretion of sodium (7)The changes in clinic blood pressure and heart rate (8)The changes in self-measured blood pressure at home