Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/30/2013 |
| Start Date: | December 2009 |
| End Date: | February 2014 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +1(862)778-8300 |
A Multi Center, Randomized , Double Blind, Placebo-controlled, Study of the Safety, Tolerability, and Effects on Arterial Structure and Function of ACZ885 in Patients With Clinically Evident Atherosclerosis and Either T2DM or IGT
This study will evaluate the effect of ACZ885 on vascular function in patients with
documented atherosclerotic disease and T2DM or IGT.
Inclusion Criteria:
- 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 Criteria:
- 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
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