Overview

Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy

Status:
Unknown status
Trial end date:
0000-00-00
Target enrollment:
600
Participant gender:
Both
Summary
Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Okayama University
Treatments:
Angiotensin-Converting Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Last Updated:
2007-01-15
Criteria
Inclusion Criteria:

- Type 2 diabetes mellitus

- Urinary albumin/creatinine ratio >= 300mg/gCr

- Serum creatinine level <2.5mg/dL through the observation period

- Patients whose consent is obtained at age >20 years or =<75 years

Exclusion Criteria:

- Type 1 diabetes mellitus

- Hereditary diabetes mellitus or secondary diabetes mellitus

- Non-diabetic nephropathy

- Familial hypercholesterolemia

- Secondary hypertension

- Unstable angina pectoris

- Myocardial infarction

- Cerebral hemorrhage

- Life-threatening disease such as malignant tumor

- History of angioedema

- Under LDL-apheresis by a adsorbent with dextran sulphate cellose

- Biliary obstruction

- Severe hepatopathy

- Hypergasia of hepatic metabolism such as acute hepatitis

- Exacerbation of chronic hepatitis

- Cirrhosis

- Hepatic cancer

- Jaundice

- History of hypersensitivity against ACE inhibitors

- History of hypersensitivity against ARB

- History of hypersensitivity against HMG-CoA reductase inhibitors

- Pregnant, lactating, and probably pregnant patients

- Patients who want to become pregnant during the study period

- Patients judged as being inappropriate for the subjects