Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2009-11-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OPC-262 5 mg
OPC-262 5 mg will be orally administered once daily fro 52 weeks.
OPC-262
OPC-262 5 mg will be orally administered once daily fro 52 weeks.
Interventions
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OPC-262
OPC-262 5 mg will be orally administered once daily fro 52 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Patients who are capable of giving informed consent
3. Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)
Exclusion Criteria
2. Patients with a medical history of diabetic coma
3. Patients with poorly-controlled hypertension
4. Patients with heart failure
5. Patients with a complication of active hepatitis or hepatic cirrhosis
6. Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
7. Patients with a history or complication of malignant tumor
20 Years
74 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chubu Region, , Japan
Kanto Region, , Japan
Tohoku Region, , Japan
Countries
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Other Identifiers
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JapicCTI-090952
Identifier Type: REGISTRY
Identifier Source: secondary_id
262-09-004
Identifier Type: -
Identifier Source: org_study_id
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