Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial

UMIN ID: UMIN000001803

Registered date:27/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertensive patients with albuminuria under the treatment of the inhibitor of the renin-angiotension system (RAS)
• Date of first enrollment: 2009/04/01
• Target sample size: 340
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Placebo is added in patients under the treatment of the RAS inhibitor. If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than aldosterone antagonist and inhibitor of RAS is added.
Eplerenone (50mg/day) is added in patients with the treatment of the RAS inhibitor. If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than aldosterone antagonist and inhibitor of RAS is added.

Outcome(s)

• Primary Outcome: Percent changes in urinary albumin/Cr ratio in first morning void urine from pretreatment period (average of 3 continuously-measured values) to 12 months of treatment
• Secondary Outcome: 1. Urinary albumin/Cr ratio in first morning void urine: Absolute value, percent changes from pretreatment period to each period of treatment, etc. 2. Urinary liver-type free fatty acid-binding protein (L-FABP) 3. Office blood pressure (BP) 4. Serum Cr or estimated glomerular filtration rate (eGFR) calculated using the modified MDRD formula in the Japanese Society of Nephrology: eGFR (ml/min/1.73 m2) = 194 x age -0.287 x serum Cr - 1.094 (multiply by 0.739 in female) 5. Estimated urinary sodium (Na) excretion for a day: Estimated urinary Na excretion for 24 hours (mmol/day) =21.98x{[urinary Na (mEq/L) / urinary Cr (mg/L)] x [-2.04 x age + 14.89 x body weight (kg) +16.14 x height (cm) - 2244.45]}0.392 6. Cerebro-cardio-vascular events: cerebro-cardio-vascular death (fatal myocardial infarction, fatal heart failure, sudden death, fatal stroke, other cardiovascular death) and hospitalization due to cerebro-cardio-vascular disease (nonfatal myocardial infarction, angina, heart failure, cerebral bleeding, cerebral infarction, transient cerebral ischemic attack)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: EVALUATE Project office
• Source(s) of Monetary Support: Pfizer Japan Inc.