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Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01919801
First received: July 25, 2013
Last updated: July 7, 2017
Last verified: July 2017
History of Changes
Results First Received: August 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Interventions: Drug: Icatibant
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 59 sites in the United States, United Kingdom, Israel and Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall 121 participants were randomized, of which 118 received the study medication, and 117 completed the study.

Reporting Groups
  Description
Icatibant 30 mg Participants received a single dose of icatibant 30 milligram (mg) subcutaneous (SC) injection within 12 hours after the onset of the angiotensin-converting enzyme inhibitor (ACE-I) induced angioedema attack.
Placebo Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.

Participant Flow:   Overall Study
    Icatibant 30 mg   Placebo
STARTED   61   60 
COMPLETED   60   57 
NOT COMPLETED   1   3 
Withdrawal by Subject                1                0 
Physician Decision                0                1 
Lost to Follow-up                0                1 
Unspecified                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) population included all randomized participants.

Reporting Groups
  Description
Icatibant 30 mg Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
Placebo Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
Total Total of all reporting groups

Baseline Measures
   Icatibant 30 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 61   60   121 
Age [1] 
[Units: Years]
Mean (Standard Deviation) 		 60.9  (12.1)   61.8  (13.4)   61.4  (12.7) 
[1] Age was calculated as the difference between date of birth and date of informed consent, rounded to 1 decimal place.
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      27  44.3%      35  58.3%      62  51.2% 
Male      34  55.7%      25  41.7%      59  48.8% 


  Outcome Measures
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1.  Primary:   Time to Meeting Discharge Criteria (TMDC)   [ Time Frame: Day 0 up to Day 5 ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)   [ Time Frame: From start of study drug administration (Day 0) up to follow-up (Day 5) ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants With Treatment Emergent Injection Site Reaction   [ Time Frame: Day 0 to Day 5 ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination   [ Time Frame: Day 0 to Day 5 ]
  Show Outcome Measure 4

5.  Secondary:   Time to Onset of Symptom Relief (TOSR)   [ Time Frame: Day 0 up to Day 5 ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema   [ Time Frame: Day 0 up to Day 5 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)   [ Time Frame: Day 0 up to Day 5 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration   [ Time Frame: Day 0 up to Day 5 ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points   [ Time Frame: 4, 6, and 8 hours post treatment ]
  Show Outcome Measure 9

10.  Other Pre-specified:   Area Under the Plasma Concentration Versus Time Curve (AUC) of Icatibant and Its Metabolites (M1 and M2)   [ Time Frame: 0.75 and 2 hours post-dose ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire
phone: 1 866-842-5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01919801     History of Changes
Other Study ID Numbers: HGT-FIR-096
2014-001213-12 ( EudraCT Number )
Study First Received: July 25, 2013
Results First Received: August 16, 2016
Last Updated: July 7, 2017