Gulati, Anil http://orcid.org/0000-0002-7420-4554
Agrawal, Nilesh
Vibha, Deepti
Misra, U. K.
Paul, Birinder
Jain, Dinesh
Pandian, Jeyaraj
Borgohain, Rupam
Clinical trials referenced in this document:
Documents that mention this clinical trial
Documents that mention this clinical trial
Safety and Efficacy of Sovateltide (IRL-1620) in a Multicenter Randomized Controlled Clinical Trial in Patients with Acute Cerebral Ischemic Stroke
https://doi.org/10.1007/s40263-020-00783-9
Article History
Accepted: 5 December 2020
First Online: 11 January 2021
Declarations
:
: Pharmazz, Inc. Willowbrook, IL, USA, provided funding for this study and paid the open access fee.
: Dr. Anil Gulati (AG) is an employee of Pharmazz, Inc. and has issued and pending patents relating to this study. Nilesh Agrawal, Deepti Vibha, UK Misra, Birinder Paul, Dinesh Jain, Jeyaraj Pandian and Rupam Borgohain have no conflicts of interest that are directly relevant to the content of this article.
: The study protocol (PMZ-01 version 2.0/April 18, 2016) was approved by the Drugs Controller General of India, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, and the institutional ethics committee of each of the seven sites (who reviewed and approved the study protocol before initiation of patient enrolment at each site). The study was registered at the Clinical Trials Registry, India (CTRI/2017/11/010654) and the US National Library of Medicine, ClinicalTrials.gov (NCT04046484).
: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
: Informed consent was obtained from each patient or from their LAR if they were not fit to give consent themselves at the time of treatment initiation. The investigator informed the patient/LAR in writing and audio-visual recording about all aspects of the study relevant to taking a decision on whether or not to participate in the study. The informed consent form included all the elements required by ICH-GCP recommendations and schedule Y.
: Not applicable.
: Not applicable.