Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
NCT ID: NCT00995930
Last Updated: 2015-06-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
189 participants
INTERVENTIONAL
2009-12-31
2014-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease
NCT01731990
Atherosclerosis in the Coronary and Carotid Arteries
NCT00080587
Cardiovascular Inflammation Reduction Trial
NCT01594333
Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study
NCT00723307
Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
NCT05708859
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
subcutaneous (SQ) monthly
Placebo
Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.
ACZ885
150 mg SQ monthly
ACZ885
ACZ885 150 mg was administered subcutaneously once a month for 12 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ACZ885
ACZ885 150 mg was administered subcutaneously once a month for 12 months.
Placebo
Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Choudhury RP, Birks JS, Mani V, Biasiolli L, Robson MD, L'Allier PL, Gingras MA, Alie N, McLaughlin MA, Basson CT, Schecter AD, Svensson EC, Zhang Y, Yates D, Tardif JC, Fayad ZA. Arterial Effects of Canakinumab in Patients With Atherosclerosis and Type 2 Diabetes or Glucose Intolerance. J Am Coll Cardiol. 2016 Oct 18;68(16):1769-1780. doi: 10.1016/j.jacc.2016.07.768.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-014618-80
Identifier Type: -
Identifier Source: secondary_id
CACZ885I2206
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.