Atherosclerosis - Clinical trial details 

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

Recruitment status:
Not recruiting
Primary Sponsor:
Novartis Pharmaceuticals
Recruitment countries:
Health condition studied:
Atherosclerosis
URL:
Link to the clinical trial website

About the trial

Interventions:
Drug: ACZ885 (Canakinumab)
Drug: Placebo
Key inclusion and exclusion 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
  • Age minimum:  18 Years
  • Age maximum:  74 Years
  • Gender:  Both
Primary outcomes:
Measure: Safety, tolerability, and effect of monthly sc administration of ACZ885 on an integrated analysis of vascular function in subjects with atherosclerosis and T2DM or IGT
Secondary outcomes:
Assess the effect of ACZ885 on beta cell function and insulin resistance
Assess the effect of ACZ885 on glycemic parameters, including HbA1c and peak glucose levels 2 hours post the administration of an OGTT
Assess the pharmacokinetics of ACZ885 in patients with atherosclerosis
Evaluate the effect of ACZ885 on hsCRP
Measure: Assess the effect of ACZ885 on aortic pulse wave velocity, plaque composition, arterial strain
Target sample size:
189
Study type:
Interventional
Study design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Contacts:

Technical details

Scientific title:
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
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT00995930
Secondary ID:
CACZ885I2206
2009-014618-80
Register:
ClinicalTrials.gov
Date of registration:
15/10/2009
Date of first enrollment:
December 2009
Last refreshed:
2 June 2014

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