UMIN ID: UMIN000000835
Registered date:15/10/2007
Assesment for Responses to Cilnidipine in Diabetic Nephropathy with Hypertension
Basic Information
Recruitment status | Complete: follow-up complete |
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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) |
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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 |
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Age maximum | 80years-old |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | non |
Secondary ID(s) |
Contact
public contact | |
Name | Shinya Fukumoto |
Address | 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan Japan |
Telephone | 06-6645-3806 |
sfukumoto@med.osaka-cu.ac.jp | |
Affiliation | Osaka City University Graduate School of Medicine Department of Metabolism, Endocrinology and Molecular Medicine |
scientific contact | |
Name | Shinya Fukumoto |
Address | 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan Japan |
Telephone | 06-6645-3806 |
Affiliation | Osaka City University Graduate School of Medicine Department of Metabolism, Endocrinology and Molecular Medicine |