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:
Canada,  Germany,  Israel,  United Kingdom,  United States
Health condition studied:
Link to the clinical trial website

About the trial

Drug: ACZ885
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

    - 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:
Change from baseline in aortic distensibility
Change from baseline in plaque burden (aortic vessel wall area and carotid vessel wall area)
Percentage of participants with adverse events, serious adverse events and death
Secondary outcomes:
Change from baseline in 2 hour glucose post oral glucose tolerance test (OGTT)
Change from baseline in aortic strain
Change from baseline in beta cell function (HOMA-B) and insulin resistance (HOMA-R)
Change from baseline in fasting plasma glucose
Change from baseline in hemoglobin A1c (HbA1c)
Change from baseline in high sensitivity C-reactive protein (hsCRP)
Change from baseline in plaque composition
Change from baseline in pulse wave velocity and puse wave velocity error
Pharmacokinetics of ACZ885: serum concentration
Target sample size:
Study type:
Study design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Name:   Novartis Pharmaceuticals
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Novartis Pharmaceuticals

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:
Secondary ID:
Date of registration:
Date of first enrollment:
December 2009
Last refreshed:
19 February 2015


Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record

Back to clinical trials list