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Trial record 31 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection

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ClinicalTrials.gov Identifier: NCT01383993
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Aspergillosis, Aspergilloma
Intervention Drug: Voriconazole
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated). Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated). Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Period Title: Overall Study
Started 15 4 2
Completed 12 3 1
Not Completed 3 1 1
Reason Not Completed
Adverse Event             1             1             0
Withdrawal by Subject             0             0             1
Marketed voriconazole in post-therapy             2             0             0
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg Total
Hide Arm/Group Description Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated). Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated). Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated). Total of all reporting groups
Overall Number of Baseline Participants 15 4 2 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 4 participants 2 participants 21 participants
7.7  (2.8) 12.5  (0.6) 14.0  (0.0) 9.2  (3.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 4 participants 2 participants 21 participants
Female
9
  60.0%
2
  50.0%
1
  50.0%
12
  57.1%
Male
6
  40.0%
2
  50.0%
1
  50.0%
9
  42.9%
1.Primary Outcome
Title Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration
Hide Description AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 4 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*h/mL
51.92
(51%)
83.39
(56%)
17.27
(28%)
2.Primary Outcome
Title Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
Hide Description [Not Specified]
Time Frame Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 4 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
7.753
(38%)
9.233
(55%)
3.092
(42%)
3.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration
Hide Description [Not Specified]
Time Frame Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 4 2
Median (Full Range)
Unit of Measure: hrs
2.96
(0.950 to 4.00)
4.00
(2.92 to 4.20)
1.34
(1.00 to 1.67)
4.Primary Outcome
Title Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration
Hide Description AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 3 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*h/mL
48.23
(83%)
59.42
(67%)
10.00 [1] 
(NA%)
[1]
Number of analyzed participant was 1.
5.Primary Outcome
Title Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration
Hide Description [Not Specified]
Time Frame Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 3 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
7.755
(50%)
7.910
(45%)
2.030 [1] 
(NA%)
[1]
Number of analyzed participant was 1.
6.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration
Hide Description [Not Specified]
Time Frame Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 3 1
Median (Full Range)
Unit of Measure: hrs
1.09
(0.917 to 3.78)
1.00
(0.950 to 2.03)
1.00
(1.00 to 1.00)
7.Primary Outcome
Title Number of Participants Assessed Near Distance Visual Acuity Test
Hide Description [Not Specified]
Time Frame Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on all subjects who received at least 1 dose of study medication.
Arm/Group Title All Participants
Hide Arm/Group Description:
Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Screening 18
The 7th day of IV treatment 18
The 1st day of oral treatment 17
The 7th day of oral treatment 15
The 30 day follow up visit 14
8.Primary Outcome
Title Number of Participants Assessed Color Vision Test
Hide Description [Not Specified]
Time Frame Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on all subjects who received at least 1 dose of study medication.
Arm/Group Title All Participants
Hide Arm/Group Description:
Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Screening 19
The 7th day of IV treatment 18
The 1st day of oral treatment 17
The 7th day of oral treatment 15
The 30 day follow up visit 14
9.Primary Outcome
Title Number of Participants Assessed Visual Questionnaire
Hide Description [Not Specified]
Time Frame Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on all subjects who received at least 1 dose of study medication.
Arm/Group Title All Participants
Hide Arm/Group Description:
Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Screening 19
The 7th day of IV treatment 18
The 1st day of oral treatment 17
The 7th day of oral treatment 15
The 30 day follow up visit 14
10.Secondary Outcome
Title Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration
Hide Description Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration
Time Frame AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 3 1
Mean (Standard Deviation)
Unit of Measure: ratio
1.077  (0.547) 0.648  (0.015) 0.476 [1]   (NA)
[1]
Number of analyzed participant was 1.
11.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Hide Description AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 4 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*h/mL
66.50
(30%)
80.99
(41%)
40.00
(2%)
12.Secondary Outcome
Title Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Hide Description [Not Specified]
Time Frame Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 4 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
6.381
(28%)
8.066
(34%)
3.835
(1%)
13.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Hide Description [Not Specified]
Time Frame Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 4 2
Median (Full Range)
Unit of Measure: hrs
5.05
(2.87 to 11.8)
4.49
(1.00 to 11.1)
3.84
(1.67 to 6.00)
14.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Hide Description AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 3 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*h/mL
79.86
(36%)
90.84
(19%)
34.40 [1] 
(NA%)
[1]
Number of analyzed participant was 1.
15.Secondary Outcome
Title Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Hide Description [Not Specified]
Time Frame Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 3 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
7.971
(31%)
8.912
(22%)
3.720 [1] 
(NA%)
[1]
Number of analyzed participant was 1.
16.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Hide Description [Not Specified]
Time Frame Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description:
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed 14 3 1
Median (Full Range)
Unit of Measure: hrs
2.07
(0.000 to 7.78)
2.03
(0.950 to 4.00)
3.80
(3.80 to 3.80)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Hide Arm/Group Description Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated). Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated). Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
All-Cause Mortality
Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/4 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants Aged 2 to <12 Years Participants Aged 12 to<15 Years and Weighed <50 kg Participants Aged 12 to<15 Years and Weighed ≥50 kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/15 (86.67%)   4/4 (100.00%)   1/2 (50.00%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  10/15 (66.67%)  2/4 (50.00%)  1/2 (50.00%) 
Histiocytosis haematophagic  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Congenital, familial and genetic disorders       
Colour blindness  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Eye disorders       
Chromatopsia  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Conjunctivitis  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Keratitis  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Photophobia  1  5/15 (33.33%)  3/4 (75.00%)  1/2 (50.00%) 
Vision blurred  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Anorectal disorder  1  0/15 (0.00%)  0/4 (0.00%)  1/2 (50.00%) 
Diarrhoea  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Lip dry  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Painful defaecation  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Stomatitis  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Toothache  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Vomiting  1  1/15 (6.67%)  1/4 (25.00%)  0/2 (0.00%) 
General disorders       
Catheter site pain  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Pyrexia  1  1/15 (6.67%)  1/4 (25.00%)  0/2 (0.00%) 
Hepatobiliary disorders       
Hepatic function abnormal  1  2/15 (13.33%)  1/4 (25.00%)  0/2 (0.00%) 
Infections and infestations       
Cystitis  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Pneumonia  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Sepsis  1  1/15 (6.67%)  1/4 (25.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Tibia fracture  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  1/15 (6.67%)  2/4 (50.00%)  0/2 (0.00%) 
Aspartate aminotransferase increased  1  1/15 (6.67%)  2/4 (50.00%)  0/2 (0.00%) 
Blood bilirubin increased  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Blood potassium decreased  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Blood pressure increased  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Blood urine present  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Gamma-glutamyltransferase increased  1  1/15 (6.67%)  1/4 (25.00%)  0/2 (0.00%) 
Liver function test abnormal  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Weight decreased  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders       
Hypoalbuminaemia  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Back pain  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Pain in extremity  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Nervous system disorders       
Headache  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Hypoxia  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Oropharyngeal pain  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis  1  2/15 (13.33%)  0/4 (0.00%)  0/2 (0.00%) 
Eczema  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Pruritus  1  1/15 (6.67%)  0/4 (0.00%)  0/2 (0.00%) 
Rash  1  3/15 (20.00%)  0/4 (0.00%)  1/2 (50.00%) 
Vascular disorders       
Hyperaemia  1  0/15 (0.00%)  1/4 (25.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01383993     History of Changes
Other Study ID Numbers: A1501096
First Submitted: June 27, 2011
First Posted: June 28, 2011
Results First Submitted: April 7, 2014
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014