Status:
UNKNOWN
Rationale and Design for Shiga Microalbuminuria Reduction Trial
Lead Sponsor:
Shiga University
Conditions:
Hypertension
Diabetes Mellitus
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief 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...
Detailed Description
Microalbuminuria in diabetic patients is an established risk marker for the progression of diabetic nephropathy and for cardiovascular mortality. Intervention trials have demonstrated that drugs that ...
Eligibility Criteria
Inclusion
- Hypertensive patient with type 2 diabetes
- Microalbuminuria defined as a urinary albumin excretion of 30 to 300 mg/gCr
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00202618
Start Date
December 1 2003
End Date
June 1 2006
Last Update
April 27 2006
Active Locations (1)
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1
Shiga University of Medical Science
Ōtsu, Shiga, Japan, 520-2192