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Sponsors and Collaborators: |
Kitasato University Tokai University Yokohama City University Medical Center St. Marianna University School of Medicine |
Information provided by: | Kitasato University |
ClinicalTrials.gov Identifier: | NCT00407680 |
To observe the effect of intensive medical treatment for type 2 diabetic patients with hypertension: to discover whether or not intensive medical treatment improves proteinuria, and the difference between the clinical meaning of responder and non-responder (criteria: 50% reduced proteinuria continuing 6 months or more during the observation period.)
Condition | Intervention | Phase |
Type 2 Diabetes Mellitus Hypertension |
Drug: Intensive therapy Valsartan,Fluvastatin |
Phase IV |
MedlinePlus related topics: | Diabetes High Blood Pressure |
ChemIDplus related topics: | Valsartan Fluvastatin Angiotensin II Angiotensin II, ile(5)- |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension |
Estimated Enrollment: | 80 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | March 2009 |
It is reported that the risk of a cardiovascular event occurring is 1.78 times higher in patients with diabetic nephropathy (DN) than in patients without DN. It is also reported that angiotensin II receptor blockade (ARB) prevents the progression of DN in diabetic patients with early phase nephropathy beyond its blood pressure lowering effect. The guidelines by the Japanese Society of Hypertension 2004 recommended that it was necessary to control blood pressure (BP) below 130/80 mmHg in all diabetic patients. This has become the universal target BP for the prevention of cardiovascular events in hypertensive patients. On the study of intensive medical treatment [including angiotensin-converting enzyme inhibitor (ACEI)], it is reported that ACEI not only prevents the progression of DN in microalbuminuria but also decreases proteinuria <1 g/day in the nephrotic syndrome. Therefore, ACEI is thought to be effective for DN. However, it is not clear whether or not intensive medical treatment (including ACEI) improves nephropathy with proteinuria >1 g/day.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Type 2 diabetic patients with hypertension, with all 5 of the criteria listed below:
Already performing dietary management
Exclusion Criteria:
Contact: Keiji Tanaka, MD,PhD | +81-427-778-8111 ext 8706 | keiji@med.kitasato-u.ac.jp |
Japan, Kanagawa | |||||
Kitasato University | Recruiting | ||||
1-15-1 Kitasato Sagamihara, Kanagawa, Japan, 228-8111 | |||||
Contact: Keiji Tanaka +81-427-8111 ext 8706 keiji@med.kitasato-u.ac.jp | |||||
Principal Investigator: Keiji Tanaka, Keiji Tanaka |
Kitasato University |
Tokai University |
Yokohama City University Medical Center |
St. Marianna University School of Medicine |
Study Chair: | Keiji Tanaka, MD,PhD | Kitasato University |
Study ID Numbers: | 8417 |
First Received: | December 4, 2006 |
Last Updated: | October 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00407680 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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