Trial · NCT01386658
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Pharmacokinetic (PK) population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Hour (h) | MEAN |
| PRIMARY | Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Nanogram per milliliter (ng/mL) | MEAN |
| PRIMARY | Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Milliliters per minute (mL/min) | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, and 4 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Hour*nanogram per milliliter (h*ng/mL) | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours Post-dose (AUC0-t) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | h*ng/mL | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | h*ng/mL | MEAN |
| PRIMARY | Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Liters (L) | MEAN |
| PRIMARY | Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | h | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Signs | Pre-dose up to 97 days post-dose | Safety population consisted of participants who were treated with icatibant at least once during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) | 6 - 8 hours post-dose on Day 1 | Safety population consisted of participants who were treated with icatibant at least once during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations | Pre-dose up to 97 days post-dose | Safety population consisted of participants who were treated with icatibant at least once during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Reported Presence of Anti-icatibant Antibodies | Pre-dose up to 97 days post-dose | Safety population consisted of participants who were treated with icatibant at least once during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) | From the start of study drug administration up to 97 days post-dose | Safety population consisted of participants who were treated with icatibant at least once during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 1 | 1 h post-dose on Day 1 up to 9 days post-dose | Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 2 and 3 | 1 h post-dose up to 9 days post-dose | Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Reproductive Hormones | Pre-dose up to 97 days post-dose | Safety population consisted of participants who were treated with icatibant at least once during the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1 | From start of study drug administration up to 8.5 hours post-dose | Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure. | h | MEDIAN |
| SECONDARY | Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3 | From start of study drug administration up to 12 hours post-dose | Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3. | h | MEDIAN |
| SECONDARY | Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1 | From start of study drug administration up to 52 hours post-dose | Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data. | h | MEDIAN |
| SECONDARY | Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3 | From start of study drug administration up to 28 hours post-dose | Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data. | h | MEDIAN |
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.
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