Trial Outcomes & Findings for Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema (NCT NCT01574248)

NCT ID: NCT01574248

Last Updated: 2017-02-17

Results Overview

Time interval between initiation of treatment and when there is no symptom, by visual analog scale \<1 cm. Data provided are for worst symptom.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2017-02-17

Participant Flow

Participant milestones

Measure	Icatibant 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Overall Study STARTED	15	18
Overall Study COMPLETED	12	18
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Icatibant 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Overall Study Withdrawal by Subject	2	0
Overall Study Missing primary endpoint data	1	0

Baseline Characteristics

Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

Baseline characteristics by cohort

Measure	Icatibant n=12 Participants 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 Participants Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours	Total n=30 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 13.4 • n=5 Participants	60.7 years STANDARD_DEVIATION 10.8 • n=7 Participants	58.9 years STANDARD_DEVIATION 11.8 • n=5 Participants
Gender Female	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Gender Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Time interval between initiation of treatment and when there is no symptom, by visual analog scale <1 cm. Data provided are for worst symptom.

Outcome measures

Measure	Icatibant n=12 Participants 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 Participants Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Time to Resolution of Angioedema	36 hours Interval 24.0 to 48.0	24 hours Interval 6.0 to 48.0

SECONDARY outcome

Timeframe: T0 to T48 hours

Outcome measures

Measure	Icatibant n=12 Participants 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 Participants Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Number of Participants With Admission to Intensive Care Unit	6 Participants	6 Participants

SECONDARY outcome

Timeframe: T0 to T48 hours

Outcome measures

Measure	Icatibant n=12 Participants 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 Participants Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Number of Participants With Requirement for Intubation	2 Participants	1 Participants

SECONDARY outcome

Timeframe: T0 to T48 hours

Outcome measures

Measure	Icatibant n=12 Participants 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 Participants Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Number of Participants Given Steroids	11 Participants	16 Participants

SECONDARY outcome

Timeframe: T0 to T48 hours

Outcome measures

Measure	Icatibant n=12 Participants 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 Participants Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers	11 Participants	16 Participants

SECONDARY outcome

Timeframe: T0 to T48 hours

Outcome measures

Measure	Icatibant n=12 Participants 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 Participants Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Number of Participants Given Epinephrine	0 Participants	3 Participants

SECONDARY outcome

Timeframe: T0 to T48 hours

Average of blood pressure measurements from zero to forty-eight hours provided.

Outcome measures

Measure	Icatibant n=12 Participants 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 Participants Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Systolic Blood Pressure	134 mmHg Standard Deviation 13	133 mmHg Standard Deviation 17

Adverse Events

Icatibant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Icatibant n=12 participants at risk 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization icatibant: Subcutaneous at time 0 and 6 hours	Placebo n=18 participants at risk Subcutaneous at time 0 and 6 hours Placebo: Subcutaneous at time 0 and 6 hours
Reproductive system and breast disorders low sperm count	0.00% 0/12	5.6% 1/18 • Number of events 1
Cardiac disorders elevated troponin	0.00% 0/12	5.6% 1/18 • Number of events 1
Immune system disorders leukocytosis	8.3% 1/12 • Number of events 1	0.00% 0/18

Additional Information

Nancy J. Brown, M.D.

Vanderbilt University Medical Center

Phone: 6153438701

Email: nancy.j.brown@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place