CompletedPhase 2

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

United States, Canada, Germany189 participantsStarted 2009-12

Plain-language summary

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

Who can participate

Age range18 Years – 74 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Adverse Events, Serious Adverse Events and Death

Timeframe: 12 months

Change From Baseline in Aortic Distensibility

Timeframe: baseline, 3 months, 12 months

Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)

Timeframe: baseline, 3 months, 12 months

Trial details

NCT IDNCT00995930

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2015-01-29

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials