Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus
Not Applicable
- Conditions
- Essential hypertension with type 2 diabetes mellitus and proteinuria
- Registration Number
- JPRN-UMIN000007456
- Lead Sponsor
- Komono Kosei Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
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%); confirmed or suspected renal artery stenosis; serum creatinine of 1.5mg/dl or more for men and 1.2mg/dl or more for women; contraindication to calcium channel blockers; 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 (1)Changes in urinary excretion of albumin from baseline to 1, 2, 4, 12 weeks after randomization (2)Changes in blood pressure and heart rate from baseline to 1, 2, 4, 12 weeks after randomization (3)Changes in urine L-FABP, OHdG, sodium, and metanephrine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine (4)Changes in serum creatinine, hs-CRP, IL-6, ADMA, cystatin C, and pentosidine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine (5)Relationship of (1) with (2) , (3), (4), (5)
- Secondary Outcome Measures
Name Time Method home BP, HbA1c