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Trial record 14 of 23 for:    ICATIBANT

Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

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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

Tracking Information
First Submitted Date  ICMJE December 14, 2011
First Posted Date  ICMJE April 10, 2012
Results First Submitted Date  ICMJE October 28, 2016
Results First Posted Date  ICMJE February 17, 2017
Last Update Posted Date February 17, 2017
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
Time to Resolution of Angioedema [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
Time to Resolution of Angioedema [ Time Frame: 48 hours ]
Time interval between when participant first noted the onset of symptom and when there is no symptom, by visual analog scale. Will also measure AUC for VAS versus time for each symptom
Change History Complete list of historical versions of study NCT01574248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • Number of Participants With Admission to Intensive Care Unit [ Time Frame: T0 to T48 hours ]
  • Number of Participants With Requirement for Intubation [ Time Frame: T0 to T48 hours ]
  • Number of Participants Given Steroids [ Time Frame: T0 to T48 hours ]
  • Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers [ Time Frame: T0 to T48 hours ]
  • Number of Participants Given Epinephrine [ Time Frame: T0 to T48 hours ]
  • Systolic Blood Pressure [ Time Frame: T0 to T48 hours ]
    Average of blood pressure measurements from zero to forty-eight hours provided.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
  • Length of hospital stay [ Time Frame: T0 to T48 hours ]
  • Admission to intensive care unit [ Time Frame: T0 to T48 hours ]
  • Requirement for intubation [ Time Frame: T0 to T48 hours ]
  • Duration of intubation [ Time Frame: T0 to T48 hours ]
  • Use of steroids [ Time Frame: T0 to T48 hours ]
  • Use of histamine receptor type 1 (H1) and type 2 (H2) blockers [ Time Frame: T0 to T48 hours ]
  • Use of epinephrine [ Time Frame: T0 to T48 hours ]
  • Blood pressure levels [ Time Frame: T0 to T48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema
Official Title  ICMJE Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema - a Mulitcenter Trial
Brief Summary Individuals with heart disease or high blood pressure are often prescribed angiotensin converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors can be associated with angioedema, a rare but life-threatening condition that causes swelling of the face and other body parts. This study will evaluate the effectiveness of the drug HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the condition.
Detailed Description

People who take ACE inhibitors may develop angioedema, a condition that causes itchy and painful swelling beneath the skin around the eyes, lips, tongue, throat, hands, or feet. In severe cases, the throat may swell, obstructing the airway and leading to breathing difficulty. ACE inhibitors prevent the breakdown of a natural chemical in the body called bradykinin. Increased levels of bradykinin, which can cause swelling, may contribute to the development of angioedema. Blocking bradykinin receptor cells prevents bradykinin from initiating swelling and may lead to a possible decrease in angioedema symptoms. The purpose of this study is to evaluate the effectiveness of HOE-140, a bradykinin receptor blocker, at reducing symptoms in people with ACE inhibitor-associated angioedema.

This study will enroll people admitted to the emergency room or hospital who have a severe case of ACE inhibitor-associated angioedema. Participants will be randomly assigned to receive an injection of either HOE-140 or placebo. Initially, participants will undergo an electrocardiogram to measure the electrical activity of the heart. Then blood pressure measurements, blood collection, a physical exam to determine the extent and duration of swelling, and photographs of the swelling will occur at 2, 4, 8, 16, and 24 hours following the start of treatment. Questionnaires will be completed by study staff and participants to assess changes in angioedema symptoms and the extent of swelling. Participants will remain in the hospital for 24 to 48 hours, depending on the severity of their symptoms. Blood will be collected at a follow-up visit that will occur 7 days after the resolution of angioedema symptoms.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ACE Inhibitor-associated Angioedema
Intervention  ICMJE
  • Drug: icatibant
    Subcutaneous at time 0 and 6 hours
    Other Names:
    • Firazyr
    • HOE140
  • Other: Placebo
    Subcutaneous at time 0 and 6 hours
Study Arms  ICMJE
  • Experimental: icatibant
    30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
    Intervention: Drug: icatibant
  • Placebo Comparator: Placebo
    Subcutaneous at time 0 and 6 hours
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
33
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2012)
32
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject has ongoing angioedema while taking an ACE inhibitor.
  • The subject is between 18 and 80 years of age.

Exclusion Criteria:

  • The subject has had angioedema while not taking an ACE inhibitor.
  • The subject's angioedema only involves the bowel.
  • The subject is known to be pregnant or has a positive urine pregnancy test.
  • The subject has started on an oral contraceptive within the last 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574248
Other Study ID Numbers  ICMJE 000626
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nancy J. Brown, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Shire
Investigators  ICMJE
Principal Investigator: Nancy J. Brown, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP