Clinical Trial: ACZ885 for the Treatment of Abdominal Aortic Aneurysm

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study of Subcutaneous ACZ885 for the Treatment of Abdominal Aortic Aneurysm

Brief Summary: This study was designed to assess the safety, tolerability and efficacy of ACZ885 on aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA). The purpose of the study was to provide data to enable decisions regarding the further development of ACZ885 for subjects with abdominal aortic aneurysms. The design of this study addressed the primary objective of evaluating the change in aneurysmal size in subjects with AAA as a result of treatment with ACZ885.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year [ Time Frame: month 3, month 12 ]

Size of the AAA was determined using an abdominal ultrasound technique at baseline, 3 months, and 12 months after treatment with study drug. Growth rate (in mm/year) was calculated from the change in AAA size compared to baseline


Original Primary Outcome: Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year [ Time Frame: Baseline, end of study (13 month) ]

Growth rate of AAA will be measured from ultrasound assessment.


Current Secondary Outcome:

Original Secondary Outcome: Number of patients with adverse events, serious adverse events and death to assess safety and tolerability of ACZ885 [ Time Frame: End of study (13 months) ]

Information By: Novartis

Dates:
Date Received: December 5, 2013
Date Started: December 2013
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016