Trial · NCT03888755
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Onset of Symptom Relief (TOSR) | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant | Hours | MEDIAN |
| SECONDARY | Time to Onset of Primary Symptom Relief (TOSR-P) | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant | Hours | MEDIAN |
| SECONDARY | Change From Baseline in the Composite Visual Analog Scale (VAS) Score | Baseline, 2, 4 and 8 hours post-treatment | The treated population included all participants treated with icatibant | Score on a scale | MEAN |
| SECONDARY | Composite Symptom Score (SS) Assessed by Investigator | 8 hours post dose | The treated population included all participants treated with icatibant | Score on a scale | MEAN |
| SECONDARY | Composite Symptom Score (SS) Assessed by Participant | 8 hours post dose | The treated population included all participants treated with icatibant | Score on a scale | MEAN |
| SECONDARY | Investigator Global Assessment | 2, 4 and 8 hours post dose | The treated population included all participants who received one dose of icatibant. | Score on a scale | MEAN |
| SECONDARY | Time to Initial Symptom Improvement by Investigator | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant | H | MEDIAN |
| SECONDARY | Time to Initial Symptom Improvement by Participants | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant. | h | MEDIAN |
| SECONDARY | Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant | H | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant | Baseline, 0.75, 2 hours post-treatment | The pharmacokinetic (PK) analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | Nano grams per milliliter (ng/mL) | MEAN |
| SECONDARY | Area Under the Concentration-time Curve From 0 to 2 Hours (AUC0-2) After a Single Subcutaneous (SC) Administration of Icatibant | Baseline, 0.75, 2 hours post-treatment | The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | Nanograms*hour per milliliter (ng•h/mL) | MEAN |
| SECONDARY | Area Under the Concentration-time Curve From 0 to 4 Hours (AUC0-4) After a Single Subcutaneous (SC) Administration of Icatibant | Baseline, 0.75, 2 hours post-treatment | The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | ng•h/mL | MEAN |
| SECONDARY | Area Under the Concentration-time Curve From 0 to 6 Hours (AUC0-6) After a Single Subcutaneous (SC) Administration of Icatibant | Baseline, 0.75, 2 hours post-treatment | The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | ng•h/mL | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration to follow-up (up to 10 days) | The treated population included all participants treated with icatibant | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Injection Site Reactions Reported as Adverse Event (AE) | From start of study drug administration to follow-up (up to 10 days) | The treated population included all participants treated with icatibant | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Adverse Event (AE) | From start of study drug administration to follow-up (up to 10 days) | The treated population included all participants treated with icatibant | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Event (AE) | From start of study drug administration to follow-up (up to 10 days) | The treated population included all participants treated with icatibant | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Adverse Event (AE) | From start of study drug administration to follow-up (up to 10 days) | The treated population included all participants treated with icatibant | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03888755/outcomes