NCT00995930

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Diabetes Mellitus, Type 2
• Atherosclerosis
• Prediabetic State

Interventions

Type	Name	Description
DRUG	ACZ885	ACZ885 150 mg was administered subcutaneously once a month for 12 months.
DRUG	Placebo	Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.

Timeline

• Start date: 2009-12-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2009-10-16
• Last updated: 2015-06-29
• Results posted: 2015-03-06

Locations

9 sites across 5 countries: United States, Canada, Germany, Israel, United Kingdom