Status:
COMPLETED
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Atherosclerosis
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.
Eligibility Criteria
Inclusion
- Patients with known atherosclerotic disease and documented diagnosis of T2DM for ≤ 14 years OR IGT
- HbA1c between 6.0% and 10.0%
- On stable statin therapy or statin intolerant
- Patients who are eligible and able to participate in the study
Exclusion
- Contraindications to MRI
- NYHA class IV Heart Failure
- NYHA class I - III heart failure with acute exacerbation in 3 months prior to screening
- Patients with type 1 diabetes
- Acute infections
- HsCRP \> 30 mg/dL
- Aortic aneurysm ≥5cm
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00995930
Start Date
December 1 2009
End Date
February 1 2014
Last Update
June 29 2015
Active Locations (9)
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1
Novartis Investigative Site
New York, New York, United States, 10029
2
Novartis Investigative Site
Cincinnati, Ohio, United States, 45219
3
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 1C8
4
Novartis Investigative Site
Mainz, Germany, 55116