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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Atherosclerosis, Prediabetic State

In brief

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

Key facts

Study ID

NCT00995930

Run by

Novartis Pharmaceuticals

People needed

189

Starts

2009-12-01

Expected to finish

2014-02-01

Last updated by the study team

2015-06-29

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Mainz, Germany
• Novartis Investigative Site — Neuss, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Jerusalem, Israel
• Novartis Investigative Site — Oxford, UK, United Kingdom
• Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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