Prospective, randomized, open-label,clinical trial comparing the effects of azilsartan and amlodipine on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases
Not Applicable
- Conditions
- Hypertension
- Registration Number
- JPRN-UMIN000011726
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy against aliskiren/amlodipine 2) Poor-controlled hypertension (DBP>110 mmHg) 3) Poor-controlled diabetes (HbA1c>8.0 %) 4) Secondary hypertension 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 7) End stage renal disease 8) Symptomatic (NYHA III or IV) congestive heart failure 9) Malignancies or other diseases with poor prognosis 10) Pregnant 11) Subjects who are taking renin-angiotensin inhibitors 11) Subjects whose doctor in charge do not agree to join the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood pressure (On visit/Home monitoring) Flow-mediated vasodilation in forearm Heparin-releasable EC-SOD levels Eight weeks after administration
- Secondary Outcome Measures
Name Time Method Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria) Eight weeks after administration