JPRN-UMIN000000846Completed未知
Primary prevention of cerebrovascular and cardiovascular events with an oral antidiabetic agent in patients with type 2 diabetes at high risk for cerebral infarction - Primary prevention for high risk Type 2 Diabetes patients in Japan:PROFIT-J
PROFIT-J Study Steering Committee0 sites500 target enrollmentStarted: October 9, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 55years-old to 85years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1 Current or past history of heart failure 2 History of treatment with a thiazolidine derivative within 8 weeks 3 Severe liver dysfunction:ALT>= 100 or viral hepatitis 4 Severe renal dysfunction:Cr>=2.5 5 Concerns about safety of a thiazolidine derivative 6 Concerns about safety of drugs to be studied 7 Cerebral hemorrhage 8 Manifest dementia 9 History of documented myocardial infarction or angina prior to registration 10 Those whom the principle investigators or other investigators consider unsuitable
Investigators
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