Rationale and Design for Shiga Microalbuminuria Reduction Trial

• Status: Unknown status
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial are to evaluate the reduction of urinary albumin excretion by an angiotensin receptor blocker (ARB), valsartan, in comparison with a calcium channel blocker (CCB), amlodipine, in Japanese hypertensive patients with type 2 diabetes mellitus and microalbuminuria under strict blood pressure control, and to compare the additional effects of an ARB or a CCB in combination with angiotensin-converting enzyme (ACE) inhibitor treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shiga University
• Treatments: Amlodipine; Valsartan

Criteria

Inclusion Criteria:

• Hypertensive patient with type 2 diabetes

• Microalbuminuria defined as a urinary albumin excretion of 30 to 300 mg/gCr

Exclusion Criteria:

• Type 1 diabetes mellitus

• Pregnant women and women of childbearing potential

• Severe hypertension (> 180/110 mmHg), malignant hypertension, secondary hypertension

• History of cardiovascular diseases in the preceding 6 months (including symptomatic heart failure, unstable angina, myocardial infarction, the performance of percutaneous transluminal coronary angioplasty [PTCA], or coronary artery bypass graft [CABG], severe arrhythmia, or second or third degree atrioventricular [AV] block)

• History of clinically significant valvular disease (e.g., aortic stenosis, mitral insufficiency)

• History of cerebral infarction, cerebral hemorrhage, or transient ischemic attack

• Serum creatinine level >1.5 mg/dl

• Persistent hematuria

• Serum potassium > 5.6 mEq/L (hyperkalemia)

• Severe hepatic disorder (e.g., hepatic failure, hepatic cirrhosis)

• Complication of an allergy of potential clinical concern

• Hypersensitivity to ARBs or CCBs

• Gastrointestinal surgery or gastrointestinal disorders which could interfere with drug absorption

• Autoimmune disease

• Participation in any intervention trial within 3 months prior to the observation period

• Patients who are unwilling or unable to comply with the trial protocol

• Concomitant use of other ARBs, CCBs, or potassium-retaining diuretics