Trial · NCT00556998
A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
NCT00556998, Phase 2, Completed, Pfizer; results first posted 2012-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents. Trials, record NCT00556998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00556998
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
- NCT number
- NCT00556998
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pharmacokinetics
- Interventions
- Voriconazole
- First posted
- 2007-11-12
- Last updated
- 2016-05-05
- Results first posted
- 2012-03-16
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration | Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion | AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method. |
| Primary | Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion | |
| Primary | Time to Reach Cmax (Tmax) Following IV Administration | Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion | |
| Primary | AUC12,ss Following Oral Administration | Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose | AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method. |
| Primary | Cmax,ss Following Oral Administration | Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose | |
| Primary | Tmax Following Oral Administration | Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose | |
| Secondary | AUC12 Following IV Loading Dose | Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion | AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method. |
| Secondary | Tmax Following an IV Loading Dose | Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion | |
| Secondary | Cmax Following an IV Loading Dose | Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion | |
| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) | Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration | Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion | Intent to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data. | μg*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Cmax (Tmax) Following IV Administration | Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | hours | MEDIAN |
| PRIMARY | AUC12,ss Following Oral Administration | Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmax,ss Following Oral Administration | Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg/mL | GEOMETRIC_MEAN |
| PRIMARY | Tmax Following Oral Administration | Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | hours | MEDIAN |
| SECONDARY | AUC12 Following IV Loading Dose | Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax Following an IV Loading Dose | Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | hours | MEDIAN |
| SECONDARY | Cmax Following an IV Loading Dose | Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Minimum Observed Plasma Trough Concentration (Cmin) | Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data. | μg/mL | GEOMETRIC_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration | Voriconazole IV | 22.39 | Standard Deviation 21.47 | μg*h/mL | |
| Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Voriconazole IV | 3.89 | Standard Deviation 2.59 | μg/mL | |
| Time to Reach Cmax (Tmax) Following IV Administration | Voriconazole IV | 1.30 | Full Range 1.17 to 3.95 | hours | |
| AUC12,ss Following Oral Administration | Voriconazole Oral | 16.74 | Standard Deviation 13.50 | μg*h/mL | |
| Cmax,ss Following Oral Administration | Voriconazole Oral | 2.35 | Standard Deviation 1.41 | μg/mL | |
| Tmax Following Oral Administration | Voriconazole Oral | 2.00 | Full Range 0.67 to 8.10 | hours | |
| AUC12 Following IV Loading Dose | Voriconazole IV | 9.14 | Standard Deviation 4.90 | μg*h/mL | |
| Tmax Following an IV Loading Dose | Voriconazole IV | 1.97 | Full Range 1.90 to 2.08 | hours | |
| Cmax Following an IV Loading Dose | Voriconazole IV | 2.25 | Standard Deviation 0.86 | μg/mL | |
| Minimum Observed Plasma Trough Concentration (Cmin) | All Treatments | IV Day 7 (up to Day 20) (n=21) | 1.05 | Standard Deviation 1.85 | μg/mL |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Voriconazole Intravenous (IV) | STARTED | All Treatments | 26 | |
| Voriconazole Intravenous (IV) | Treated | All Treatments | 26 | |
| Voriconazole Intravenous (IV) | COMPLETED | All Treatments | 21 | |
| Voriconazole Intravenous (IV) | NOT COMPLETED | All Treatments | 5 | |
| Voriconazole Oral | STARTED | All Treatments | 22 | |
| Voriconazole Oral | COMPLETED | All Treatments | 20 | |
| Voriconazole Oral | NOT COMPLETED | All Treatments | 2 |
Source ClinicalTrials.gov
Adverse events486
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 | Anaemia | Blood and lymphatic system disorders | Voriconazole IV | 1 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Voriconazole Oral | 2 | 22 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Voriconazole IV | 1 | 26 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Voriconazole Oral | 2 | 22 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Voriconazole IV | 1 | 26 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Voriconazole Oral | 0 | 22 | |
| other | Leukopenia | Blood and lymphatic system disorders | Voriconazole IV | 1 | 26 | |
| other | Leukopenia | Blood and lymphatic system disorders | Voriconazole Oral | 1 | 22 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole IV | 3 | 26 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole Oral | 2 | 22 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voriconazole IV | ||
| Total, all-cause mortality | Voriconazole Oral | ||
| Total, other adverse events | Voriconazole IV | 26 | 26 |
| Total, other adverse events | Voriconazole Oral | 22 | 22 |
| Total, serious adverse events | Voriconazole IV | 4 | 26 |
| Total, serious adverse events | Voriconazole Oral | 4 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Voriconazole IV vs Voriconazole Oral: serious adverse events |
Source 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.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00556998
GET https://conductscience.org/api/trials/v1/NCT00556998/registered?page=2