Assesment for Response to Candesartan in Diabetic Nephropathy

UMIN ID: UMIN000000497

Registered date:31/12/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertensive patients with diabetic nephropathy
• Date of first enrollment: 2002/04/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

High-dose ARB group: Candesartan 12mg/day
low-dose ARB group: Candesartan 4mg/day
Non renin-angiotensin (RA) system inhibiting agents treated group: ARB and angiotensin converting enzyme (ACE) inhibitor are not administered

Outcome(s)

• Primary Outcome: 1. Urinary albumin, urinary protein 2. Serum creatinin
• Secondary Outcome: Cardiovascular events: cardiovascular death, endstage renal failure, heart failure, stroke, total death Laboratory data: Oxidative stress markers, chest X ray, electrocardiography, carotid artery echo (intima media thickness: IMT), palse wave verosity (PWV), echocardiography (left ventricular mass index)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Severe hypertension: 180/110 mmHg or above. 2. Severe cardiovascular conplication 3. Severe diabetes 4. Pregnancy 5. History of severe side effect of ARB or ACE inhibitor 6. Patients who are treating with ARB or ACE inhibitor 7. Patients who are inadequate to enty this study by physisicans in charge.

Related Information

• Primary Sponsor: University of Tokyo Graduate School of Medicine
• Source(s) of Monetary Support: Department account fund