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Authors
Gulati, Anil https://orcid.org/0000-0002-7420-4554
Adwani, Sikandar Gokuldas
Vijaya, Pamidimukkala
Agrawal, Nilesh Radheshyam
Ramakrishnan, T. C. R.
Rai, Hari Prakash
Jain, Dinesh
Sundarachary, Nagarjunakonda Venkata
Pandian, Jeyaraj Durai
Sardana, Vijay
Sharma, Mridul
Sidhu, Gursaran Kaur
Anand, Sidharth Shankar
Vibha, Deepti
Aralikatte, Saroja
Khurana, Dheeraj
Joshi, Deepika
Karadan, Ummer
Siddiqui, Mohd. Shafat Imam
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04047563 at ClinicalTrials.govDocuments that mention this clinical trial
Efficacy and Safety of Sovateltide in Patients with Acute Cerebral Ischaemic Stroke: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase III Clinical Trial
https://doi.org/10.1007/s40265-024-02121-5
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Funding
Funding for this research was provided by:
Pharmazz, Inc.
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Article History
Accepted: 2 November 2024
First Online: 15 November 2024
Declarations
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: Pharmazz Inc., Willowbrook, IL, USA, funded the study. The funder contributed and reviewed the study design and protocol but had no role in conducting the study, data collection, management, analysis, and interpretation. All the authors had access to the data and have reviewed and approved the preparation and submission of this manuscript for publication.
: Anil Gulati has issued and pending patents and is an employee and stockholder of Pharmazz Inc. No conflicts related to the content of this article are reported by Sikandar Gokuldas Adwani, Pamidimukkala Vijaya, Nilesh Radheshyam Agrawal, TCR Ramakrishnan, Hari Prakash Rai, Dinesh Jain, Nagarjunakonda Venkata Sundarachary, Jeyaraj Durai Pandian, Vijay Sardana, Mridul Sharma, Gursaran Kaur Sidhu, Sidharth Shankar Anand, Deepti Vibha, Saroja Aralikatte, Dheeraj Khurana, Deepika Joshi, Ummer Karadan, Mohd. Shafat Imam Siddiqui.
: The study protocol PMZ-1620/CT-3.1/2019) dated April 29, 2019, was approved by the Drugs Controller General of India (DCGI) (DCGI CT NOC. No.: CT/ND/66/2019). Furthermore, each institutional ethics committee reviewed and approved the study protocol before initiating patient enrolment. The trial registration was done at the Clinical Trials Registry, India (CTRI/2019/09/021373) and the United States National Library of Medicine, ClinicalTrials.gov (NCT04047563).
: Informed written consent was obtained from patients or their legally authorised representatives.
: Not applicable.
: Not applicable.
: The anonymised patient datasets created and/or analysed for the current study can be accessed from the corresponding author at a reasonable request from a bona fide researcher/research group.
: Study concept and design: AG and JDP; Investigation: SGA, PV, NRA, TCRR, HPR, DJ, NVS, JDP, VS, MS, GKS, SSA, DV, SA, DK, DJ, UK, and MSIS; Acquisition of data: SGA, PV, NRA, TCRR, HPR, DJ, NVS, JDP, VS, MS, GKS, SSA, DV, SA, DK, DJ, UK, and MSIS; Analysis and interpretation of data: AG; Drafting of the manuscript: AG; Review of the manuscript: SGA, PV, NRA, TCRR, HPR, DJ, NVS, JDP, VS, MS, GKS, SSA, DV, SA, DK, DJ, UK, and MSIS. All authors contributed to the data collection, had full access to the data room having all the data in the study, and accept responsibility to submit for publication.
