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Trial record 14 of 23 for:    ICATIBANT

Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574248
Recruitment Status : Terminated (DSMC recommended discontinuation for futility and feasibility)
First Posted : April 10, 2012
Results First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition ACE Inhibitor-associated Angioedema
Interventions Drug: icatibant
Other: Placebo
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Period Title: Overall Study
Started 15 18
Completed 12 18
Not Completed 3 0
Reason Not Completed
Withdrawal by Subject             2             0
Missing primary endpoint data             1             0
Arm/Group Title Icatibant Placebo Total
Hide Arm/Group Description

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Total of all reporting groups
Overall Number of Baseline Participants 12 18 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 18 participants 30 participants
56.3  (13.4) 60.7  (10.8) 58.9  (11.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 18 participants 30 participants
Female
7
  58.3%
12
  66.7%
19
  63.3%
Male
5
  41.7%
6
  33.3%
11
  36.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 18 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  75.0%
11
  61.1%
20
  66.7%
White
3
  25.0%
7
  38.9%
10
  33.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 18 participants 30 participants
12
 100.0%
18
 100.0%
30
 100.0%
1.Primary Outcome
Title Time to Resolution of Angioedema
Hide Description Time interval between initiation of treatment and when there is no symptom, by visual analog scale <1 cm. Data provided are for worst symptom.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Overall Number of Participants Analyzed 12 18
Median (95% Confidence Interval)
Unit of Measure: hours
36
(24 to 48)
24
(6 to 48)
2.Secondary Outcome
Title Number of Participants With Admission to Intensive Care Unit
Hide Description [Not Specified]
Time Frame T0 to T48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Overall Number of Participants Analyzed 12 18
Measure Type: Count of Participants
Unit of Measure: Participants
6
  50.0%
6
  33.3%
3.Secondary Outcome
Title Number of Participants With Requirement for Intubation
Hide Description [Not Specified]
Time Frame T0 to T48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Overall Number of Participants Analyzed 12 18
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
1
   5.6%
4.Secondary Outcome
Title Number of Participants Given Steroids
Hide Description [Not Specified]
Time Frame T0 to T48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Overall Number of Participants Analyzed 12 18
Measure Type: Count of Participants
Unit of Measure: Participants
11
  91.7%
16
  88.9%
5.Secondary Outcome
Title Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers
Hide Description [Not Specified]
Time Frame T0 to T48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Overall Number of Participants Analyzed 12 18
Measure Type: Count of Participants
Unit of Measure: Participants
11
  91.7%
16
  88.9%
6.Secondary Outcome
Title Number of Participants Given Epinephrine
Hide Description [Not Specified]
Time Frame T0 to T48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Overall Number of Participants Analyzed 12 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  16.7%
7.Secondary Outcome
Title Systolic Blood Pressure
Hide Description Average of blood pressure measurements from zero to forty-eight hours provided.
Time Frame T0 to T48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

Overall Number of Participants Analyzed 12 18
Mean (Standard Deviation)
Unit of Measure: mmHg
134  (13) 133  (17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description

30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization

icatibant: Subcutaneous at time 0 and 6 hours

Subcutaneous at time 0 and 6 hours

Placebo: Subcutaneous at time 0 and 6 hours

All-Cause Mortality
Icatibant Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Icatibant Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Icatibant Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      2/18 (11.11%)    
Cardiac disorders     
elevated troponin *  0/12 (0.00%)  0 1/18 (5.56%)  1
Immune system disorders     
leukocytosis   1/12 (8.33%)  1 0/18 (0.00%)  0
Reproductive system and breast disorders     
low sperm count *  0/12 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nancy J. Brown, M.D.
Organization: Vanderbilt University Medical Center
Phone: 6153438701
EMail: nancy.j.brown@vanderbilt.edu
Publications:
Layout table for additonal information
Responsible Party: Nancy J. Brown, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01574248     History of Changes
Other Study ID Numbers: 000626
First Submitted: December 14, 2011
First Posted: April 10, 2012
Results First Submitted: October 28, 2016
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017