Sano, Yamato http://orcid.org/0000-0002-5512-2190
Shoji, Satoshi
Shahin, Mohamed
Sweeney, Kevin
Darekar, Amanda
Malhotra, Bimal K
Clinical trials referenced in this document:
Documents that mention this clinical trial
Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity
https://doi.org/10.1007/s13318-023-00818-8
Documents that mention this clinical trial
Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity
https://doi.org/10.1007/s13318-023-00818-8
Article History
Accepted: 6 February 2023
First Online: 9 March 2023
Declarations
:
: This study was funded by Pfizer Inc. All authors are employees and shareholders of Pfizer Inc.
: All authors are employees and shareholders of Pfizer Inc.
: Upon request, and subject to certain criteria, conditions and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
: The NONMEM code is in Online Resource 4 and Online Resource 5. The R code for the simulation describing the assessment of the impact of body weight on MCC is in Online Resource 6. Other R codes used to generate the graphics can be obtained from the corresponding author on reasonable request.
: YS analyzed the data. All authors made substantial contributions to the interpretation of data and participated in drafting and critically revising the work. All authors approved the final version to be published and agree to be accountable for all aspects of the work.
: The study protocols were approved by the institutional review boards/ethics committees of the study sites, and all participants provided written informed consent before participation in the studies. The studies were conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and conducted according to the International Conference on Harmonization Guidelines for Good Clinical Practice.
: All participants provided written informed consent before participation in the studies.
: Not applicable.
: These analyses included data from the following studies: NCT00857896 and NCT01557244