Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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