Assesment for Responses to Cilnidipine in Diabetic Nephropathy with Hypertension

UMIN ID: UMIN000000835

Registered date:15/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Diabetic nephropathy with hypertension
• Date of first enrollment: 2007/08/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

L-CCB/Cilnidipine group: Switch to 6 month-treatment with cilnidipine after L-CCB administration for at least 6 months
Cilnidipine/L-CCB group: Switch to 6 month-treatment with L-CCB after cilnidipine administration for at least 6 months

Outcome(s)

• Primary Outcome: 1. Change in urinary excretion of albumin or protein 2. Change in serum creatinin level or GFR 3. Blood pressure lowering effects. Achievement of target blood pressure, <130/80 mmHg (<125/75 mmHg in case of more than 1g/day of urinary protein excretion)
• Secondary Outcome: Change in plasma glucose, HbA1C, insulin, total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol, urinary NAG excretion, or blood AGE levels, urinary BMG.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: (1) Contraindication to Ca-channel blocker (2) The patient who is judged to be inappropriate for this study by the doctor in charge.

Related Information

• Primary Sponsor: Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine
• Source(s) of Monetary Support: non