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Authors
Ferguson-Sells, Lisa https://orcid.org/0000-0001-6507-7672
Velez de Mendizabal, Nieves
Li, Baohui
Small, David
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Clinical Trials BETA
Clinical trials referenced in this document:
nct01484431 at ClinicalTrials.govnct00125918 at ClinicalTrials.govDocuments that mention this clinical trial
Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model
https://doi.org/10.1007/s40262-021-01052-8
Documents that mention this clinical trial
Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model
https://doi.org/10.1007/s40262-021-01052-8
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Funding
Funding for this research was provided by:
Eli Lilly and Company
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Article History
Accepted: 11 June 2021
First Online: 11 August 2021
Declarations
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: This study was funded by Eli Lilly and Company.
: Lisa Ferguson-Sells and Baohui Li are employees of Eli Lilly and Company and own stocks. David Small and Nieves Velez de Mendizabal are former employees of Eli Lilly and Company. NVM is an employee of Metrum Research Group, Tariffville, CT, USA, and DS is an employee of Karuna Therapeutics, Boston, MA, USA.
: Both studies (LVIG and PHIRST-1) were conducted in accordance with consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines; the International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guideline [E6]; and applicable local laws and regulations. The local Ethics Review Committees approved the protocols, and written informed consent was obtained from patients or legal guardians prior to a patient’s participation.
: Informed consent was obtained from all individual participants included in the study.
: Not applicable.
: Eli Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of PK or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU, and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at .
: Not applicable.
: LF-S, BL, and DS conceptualized and designed the study; LF-S and BL acquired data for the study; and LF-S, NVM, BL, and DS analyzed and interpreted the data, drafted the paper, and critically revised the paper.
