Trial · NCT01919801

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

NCT01919801, Phase 3, Completed, Shire; results first posted 2016-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema. Trials, record NCT01919801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01919801

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema
NCT number: NCT01919801
Status: Completed
Phases: Phase 3
Enrollment: 118 participants, actual
Lead sponsor: Shire
Conditions: Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Interventions: Icatibant, Placebo
First posted: 2013-08-09
Last updated: 2021-06-08
Other registries' IDs: eudract:2014-001213-12
Results first posted: 2016-10-10

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Meeting Discharge Criteria (TMDC)	Day 0 up to Day 5	TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)	From start of study drug administration (Day 0) up to follow-up (Day 5)	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Primary	Number of Participants With Treatment Emergent Injection Site Reaction	Day 0 to Day 5	Injection site reaction included erythema, swelling, cutaneous pain, burning sensation, itching and warm sensation
Primary	Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination	Day 0 to Day 5	During laboratory evaluation, serum chemistry and hematology blood tests, and urinalysis were performed. Vital signs parameters included evaluation of pulse rate and systolic and diastolic blood pressure. Standard 12-lead ECGs were performed and ECG recordings were read locally at the study site by a cardiologist. Physical examination was performed with examination of major body systems per routine clinical practice.
Secondary	Time to Onset of Symptom Relief (TOSR)	Day 0 up to Day 5	TOSR was calculated for the individual symptoms with pre-treatment scores of 2 (moderate) or more improved by at least 1 severity grade and the individual symptoms with pretreatment scores of 0 or 1 (absent or mild) were scored again at 0 or 1 and all the subsequent assessments continued to satisfy this condition. Time-to-event data were summarized using Kaplan-Meier estimates.
Secondary	Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema	Day 0 up to Day 5	Airway Intervention included intubation, tracheotomy, cricothyrotomy.
Secondary	Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)	Day 0 up to Day 5	Number of participants with and without an occurrence of admission to the hospital (inpatient) or ICU post-treatment due to the ACE-I-induced angioedema attack were described.
Secondary	Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration	Day 0 up to Day 5	Number of participants with the use of conventional medications (corticosteroids, antihistamines, epinephrine) for the treatment of symptoms of the ACE-I- induced angioedema attack following study drug administration were presented.
Secondary	Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points	4, 6, and 8 hours post treatment	TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.
Other	Area Under the Plasma Concentration Versus Time Curve (AUC) of Icatibant and Its Metabolites (M1 and M2)	0.75 and 2 hours post-dose	Area under the plasma concentration-time curve of Icatibant and its metabolites (M1 and M2) were analyzed. A population pharmacokinetic analysis approach using sparse pharmacokinetic sampling obtained from a subset of subjects was used to evaluate exposure to icatibant.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Meeting Discharge Criteria (TMDC)	Day 0 up to Day 5	Intent-to-treat (ITT) population included all randomized participants.	days	MEDIAN
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)	From start of study drug administration (Day 0) up to follow-up (Day 5)	Safety population included all participants who received the study drug.	participants	NUMBER
PRIMARY	Number of Participants With Treatment Emergent Injection Site Reaction	Day 0 to Day 5	Safety population.	participants	NUMBER
PRIMARY	Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination	Day 0 to Day 5	Safety population.	participants	NUMBER
SECONDARY	Time to Onset of Symptom Relief (TOSR)	Day 0 up to Day 5	ITT population.	days	MEDIAN
SECONDARY	Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema	Day 0 up to Day 5	Modified Intent to treat (mITT) population included all randomized participants who received the study drug.	participants	NUMBER
SECONDARY	Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)	Day 0 up to Day 5	mITT population.	participants	NUMBER
SECONDARY	Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration	Day 0 up to Day 5	mITT population.	participants	NUMBER
SECONDARY	Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points	4, 6, and 8 hours post treatment	mITT population.	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Area Under the Plasma Concentration Versus Time Curve (AUC) of Icatibant and Its Metabolites (M1 and M2)	0.75 and 2 hours post-dose	PK analysis population.	hoursnanogram per milliliter (hng/mL)	MEAN

Source ClinicalTrials.gov

Results by group37

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Meeting Discharge Criteria (TMDC)	Icatibant 30 mg		4.03	Inter-Quartile Range 2.03 to 6.00	days
Time to Meeting Discharge Criteria (TMDC)	Placebo		4.00	Inter-Quartile Range 1.03 to 6.00	days
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)	Icatibant 30 mg	Participants with TEAEs	27		participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)	Placebo	Participants with TEAEs	21		participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)	Icatibant 30 mg	Participants with TESAEs	2		participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)	Placebo	Participants with TESAEs	1		participants
Number of Participants With Treatment Emergent Injection Site Reaction	Icatibant 30 mg	Erythema	31		participants
Number of Participants With Treatment Emergent Injection Site Reaction	Placebo	Erythema	13		participants
Number of Participants With Treatment Emergent Injection Site Reaction	Icatibant 30 mg	Swelling	17		participants
Number of Participants With Treatment Emergent Injection Site Reaction	Placebo	Swelling	13		participants

1 to 10 of 37Source ClinicalTrials.gov

See all 37 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Icatibant 30 mg	61
Overall Study	STARTED	Placebo	60
Overall Study	COMPLETED	Icatibant 30 mg	60
Overall Study	COMPLETED	Placebo	57
Overall Study	NOT COMPLETED	Icatibant 30 mg	1
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Icatibant 30 mg	0	60	0
other	Nausea	Gastrointestinal disorders	Placebo	3	58	3
other	Headache	Nervous system disorders	Icatibant 30 mg	7	60	7
other	Headache	Nervous system disorders	Placebo	4	58	4
other	Dysphonia	Respiratory, thoracic and mediastinal disorders	Icatibant 30 mg	3	60	4
other	Dysphonia	Respiratory, thoracic and mediastinal disorders	Placebo	2	58	2
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Icatibant 30 mg	1	60	1
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Placebo	3	58	3
other	Angioedema	Skin and subcutaneous tissue disorders	Icatibant 30 mg	7	60	9
other	Angioedema	Skin and subcutaneous tissue disorders	Placebo	2	58	4

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Icatibant 30 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Icatibant 30 mg	14	60
Total, other adverse events	Placebo	11	58
Total, serious adverse events	Icatibant 30 mg	2	60
Total, serious adverse events	Placebo	1	58

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28552382	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Icatibant 30 mg vs Placebo: Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination	Trial comparisons
Icatibant 30 mg vs Placebo: Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration	Trial comparisons
Icatibant 30 mg vs Placebo: Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema	Trial comparisons
Icatibant 30 mg vs Placebo: Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)	Trial comparisons
Icatibant 30 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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