Status:
COMPLETED
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
Lead Sponsor:
Synvista Therapeutics, Inc
Conditions:
Acute Coronary Syndrome
Type 2 Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous intervention (PCI), a procedur...
Detailed Description
Following screening, baseline measurements and informed consent, patients will receive BXT-51072 40 mg or placebo in a 2:1 ratio, 30 minutes before their scheduled PCI and then three times per day for...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days
Exclusion
- CK-MB above normal
- Elevated troponin not showing a decreasing value
- Congestive heart failure
- Atrial fibrillation or left bundle branch block
- Uncontrolled diabetes
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00320502
Start Date
May 1 2006
End Date
August 1 2008
Last Update
August 25 2008
Active Locations (4)
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1
Rambam Medical Center
Haifa, Israel, 31096
2
Western Galilee Hospital
Nahariya, Israel, 22100
3
Rivka Sieff Hospital
Safed, Israel, 13100
4
Sourasky Medical Center
Tel Aviv, Israel, 64239