Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial
- Conditions
- Hypertensive patients with albuminuria under the treatment of the inhibitor of the renin-angiotension system (RAS)
- Registration Number
- JPRN-UMIN000001803
- Lead Sponsor
- EVALUATE Project office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 340
Not provided
1. Hypertensive emergency that requires intravenous administration of antihypertensives 2. Aldosterone antagonist has been administered within 8 weeks when the interim registration is done 3. Administration of adrenocorticosteroidal drug, immunosuppressant or long-term (equal or more than 2 weeks) administration of non-steroid anti-inflammatory drugs (NSAID) 4. Serum potassium (K) is equal or more than 5.0 mEq/L 5. Fasting blood glucose is equal or more than 126 mg/dL or anti-diabetic drug is administered. 6. Severe liver damage (Child-Pugh Score: class C) 7. Sever heart failure (NYHA class is equal or more than 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), angina, or myocardial infarction within 6 months 8. Cerebrovascular disease occurs within 6 months 9. Pregnant, possible to be pregnant, or willing to be pregnant 10. Past history of severe side effect of aldosterone antagonist, ACE inhibitor or ARB 11. Supplementation of K or administration of K-sparing diuretics, itraconazole, ritonavir, or nelfinavir. 12. Patients who are inadequate by determination of physician in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method