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ACZ885 for the Treatment of Abdominal Aortic Aneurysm (AAA)

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ClinicalTrials.gov Identifier: NCT02007252
Recruitment Status : Terminated (The results of a third interim analysis (ad hoc) indicated a lack of efficacy and futility in continuing the trial.)
First Posted : December 10, 2013
Results First Posted : November 21, 2016
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Abdominal Aortic Aneurysm (AAA)
Interventions Drug: ACZ885
Drug: Placebo
Enrollment 65
Recruitment Details  
Pre-assignment Details A total of 65 participants were randomized in a 1:1 ratio to one of the two treatment groups. One participant discontinued prior to taking any study medication. As such, the participant flow is based on 64 randomized participants.
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
Period Title: Overall Study
Started 31 33
Safety Analysis Set 31 33
Pharmacodynamic Analysis Set 31 33
Completed 20 22
Not Completed 11 11
Reason Not Completed
Administrative problems             3             7
Abnormal laboratory value(s)             1             0
Adverse Event             7             4
Arm/Group Title ACZ885 Placebo Total
Hide Arm/Group Description Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. Participants received matching placebo to ACZ885 s.c. once per month for 12 months. Total of all reporting groups
Overall Number of Baseline Participants 31 33 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 33 participants 64 participants
69.4  (7.44) 70.8  (5.84) 70.1  (6.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Female
4
  12.9%
7
  21.2%
11
  17.2%
Male
27
  87.1%
26
  78.8%
53
  82.8%
1.Primary Outcome
Title Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year
Hide Description 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
Time Frame month 3, month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacodynamic analysis set, which included randomized participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at each time point were analyzed.
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description:
Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
Overall Number of Participants Analyzed 31 33
Least Squares Mean (90% Confidence Interval)
Unit of Measure: millimeter/year
Month 3 (n=23,31)
0.781
(-0.942 to 5.504)
2.519
(1.030 to 4.008)
Month 12 (n=20,23)
2.538
(1.465 to 3.612)
2.581
(1.612 to 3.549)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACZ885, Placebo
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.1037
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ACZ885, Placebo
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.4806
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
All-Cause Mortality
ACZ885 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACZ885 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/31 (6.45%)   0/33 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture  1  1/31 (3.23%)  0/33 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  1/31 (3.23%)  0/33 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACZ885 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   28/31 (90.32%)   28/33 (84.85%) 
Blood and lymphatic system disorders     
Anaemia  1  1/31 (3.23%)  0/33 (0.00%) 
Cardiac disorders     
Angina pectoris  1  0/31 (0.00%)  2/33 (6.06%) 
Atrial fibrillation  1  2/31 (6.45%)  0/33 (0.00%) 
Atrioventricular block second degree  1  0/31 (0.00%)  1/33 (3.03%) 
Eye disorders     
Cataract  1  0/31 (0.00%)  1/33 (3.03%) 
Gastrointestinal disorders     
Abdominal pain  1  3/31 (9.68%)  1/33 (3.03%) 
Abdominal pain upper  1  2/31 (6.45%)  0/33 (0.00%) 
Diarrhoea  1  1/31 (3.23%)  1/33 (3.03%) 
Gastric ulcer  1  0/31 (0.00%)  1/33 (3.03%) 
Gastrooesophageal reflux disease  1  0/31 (0.00%)  2/33 (6.06%) 
Haematochezia  1  0/31 (0.00%)  1/33 (3.03%) 
Nausea  1  1/31 (3.23%)  0/33 (0.00%) 
Oesophagitis  1  0/31 (0.00%)  1/33 (3.03%) 
Vomiting  1  0/31 (0.00%)  1/33 (3.03%) 
General disorders     
Energy increased  1  1/31 (3.23%)  0/33 (0.00%) 
Fatigue  1  2/31 (6.45%)  0/33 (0.00%) 
Impaired healing  1  1/31 (3.23%)  1/33 (3.03%) 
Influenza like illness  1  0/31 (0.00%)  1/33 (3.03%) 
Injection site hypersensitivity  1  1/31 (3.23%)  0/33 (0.00%) 
Injection site pain  1  1/31 (3.23%)  1/33 (3.03%) 
Injection site swelling  1  3/31 (9.68%)  2/33 (6.06%) 
Malaise  1  1/31 (3.23%)  0/33 (0.00%) 
Oedema peripheral  1  0/31 (0.00%)  4/33 (12.12%) 
Infections and infestations     
Erysipelas  1  1/31 (3.23%)  0/33 (0.00%) 
Gastroenteritis  1  0/31 (0.00%)  1/33 (3.03%) 
Influenza  1  0/31 (0.00%)  1/33 (3.03%) 
Nasopharyngitis  1  5/31 (16.13%)  3/33 (9.09%) 
Pneumonia  1  2/31 (6.45%)  1/33 (3.03%) 
Respiratory tract infection  1  0/31 (0.00%)  1/33 (3.03%) 
Rhinitis  1  2/31 (6.45%)  1/33 (3.03%) 
Sinusitis  1  1/31 (3.23%)  0/33 (0.00%) 
Tooth infection  1  0/31 (0.00%)  1/33 (3.03%) 
Upper respiratory tract infection  1  2/31 (6.45%)  1/33 (3.03%) 
Urinary tract infection  1  2/31 (6.45%)  1/33 (3.03%) 
Vestibular neuronitis  1  1/31 (3.23%)  0/33 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/31 (3.23%)  1/33 (3.03%) 
Foot fracture  1  0/31 (0.00%)  1/33 (3.03%) 
Ligament sprain  1  1/31 (3.23%)  1/33 (3.03%) 
Wound  1  0/31 (0.00%)  1/33 (3.03%) 
Investigations     
Alanine aminotransferase increased  1  0/31 (0.00%)  2/33 (6.06%) 
Aspartate aminotransferase increased  1  0/31 (0.00%)  2/33 (6.06%) 
Blood creatinine increased  1  1/31 (3.23%)  0/33 (0.00%) 
Blood glucose increased  1  0/31 (0.00%)  1/33 (3.03%) 
International normalised ratio increased  1  1/31 (3.23%)  0/33 (0.00%) 
Occult blood positive  1  2/31 (6.45%)  0/33 (0.00%) 
Prostatic specific antigen increased  1  0/31 (0.00%)  1/33 (3.03%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/31 (0.00%)  1/33 (3.03%) 
Hypercholesterolaemia  1  1/31 (3.23%)  2/33 (6.06%) 
Hyperlipidaemia  1  1/31 (3.23%)  0/33 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/31 (6.45%)  2/33 (6.06%) 
Back pain  1  4/31 (12.90%)  3/33 (9.09%) 
Groin pain  1  1/31 (3.23%)  0/33 (0.00%) 
Musculoskeletal pain  1  1/31 (3.23%)  0/33 (0.00%) 
Myalgia  1  1/31 (3.23%)  1/33 (3.03%) 
Osteoarthritis  1  1/31 (3.23%)  0/33 (0.00%) 
Osteoporosis  1  1/31 (3.23%)  0/33 (0.00%) 
Pain in extremity  1  0/31 (0.00%)  1/33 (3.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer stage 0, with cancer in situ  1  1/31 (3.23%)  0/33 (0.00%) 
Nervous system disorders     
Amnesia  1  1/31 (3.23%)  0/33 (0.00%) 
Dizziness  1  0/31 (0.00%)  1/33 (3.03%) 
Headache  1  2/31 (6.45%)  0/33 (0.00%) 
Sciatica  1  1/31 (3.23%)  1/33 (3.03%) 
Syncope  1  1/31 (3.23%)  0/33 (0.00%) 
Transient ischaemic attack  1  1/31 (3.23%)  0/33 (0.00%) 
Psychiatric disorders     
Depression  1  1/31 (3.23%)  0/33 (0.00%) 
Insomnia  1  1/31 (3.23%)  1/33 (3.03%) 
Renal and urinary disorders     
Urinary retention  1  1/31 (3.23%)  1/33 (3.03%) 
Reproductive system and breast disorders     
Breast cyst  1  1/31 (3.23%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/31 (3.23%)  2/33 (6.06%) 
Cough  1  3/31 (9.68%)  1/33 (3.03%) 
Dyspnoea  1  0/31 (0.00%)  1/33 (3.03%) 
Epistaxis  1  1/31 (3.23%)  0/33 (0.00%) 
Haemoptysis  1  0/31 (0.00%)  1/33 (3.03%) 
Oropharyngeal pain  1  0/31 (0.00%)  1/33 (3.03%) 
Skin and subcutaneous tissue disorders     
Blister  1  1/31 (3.23%)  0/33 (0.00%) 
Night sweats  1  1/31 (3.23%)  0/33 (0.00%) 
Telangiectasia  1  1/31 (3.23%)  0/33 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  1/31 (3.23%)  2/33 (6.06%) 
Hot flush  1  0/31 (0.00%)  1/33 (3.03%) 
Hypertension  1  4/31 (12.90%)  3/33 (9.09%) 
Intermittent claudication  1  1/31 (3.23%)  0/33 (0.00%) 
Thrombophlebitis  1  1/31 (3.23%)  0/33 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02007252     History of Changes
Other Study ID Numbers: CACZ885X2201
2013-002088-25 ( EudraCT Number )
First Submitted: December 5, 2013
First Posted: December 10, 2013
Results First Submitted: September 29, 2016
Results First Posted: November 21, 2016
Last Update Posted: April 9, 2019