Administrative information
Title {1} | Protocol for a phase 2, Randomized, Double Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction |
Trial registration {2a and 2b}. | IND Number: 123717 EudraCT No.: 2018-000916-75 |
Protocol version {3} | 1.3 (10 October 2019) |
Funding {4} | This research is funded by the sponsor RECARDIO, Inc., 1 Market Street San Francisco, CA 94150, USA. |
Author details {5a} | Dirk von Lewinski 1*, Joseph B Selvanayagam 2, Richard A Schatz 3, Bernd Jilma 4, Jacek Kubica 5, Tom Povsic 6, Darrell Nix 7, Stephan Henauer 7, and Markus Wallner 1,8,9 on behalf of the REC-DUT-002 study group 1Department of Cardiology, Medical University of Graz, Austria 2Department of Cardiovascular Medicine, Flinders University of South Australia, South Australian Health and Medical Research Institute, Australia 3Gene and Cell Therapy, Scripps Clinic, La Jolla, USA 4Department of Clinical Pharmacology, Medical University of Vienna, Austria 5Nicolaus Copernicus University, Bydgoszcz, Poland 6Heart Center Clinical Research, Duke University, Durham, NC, USA 7RECARDIO Inc., San Francisco, CA, USA 8Cardiovascular Research Center, Lewis Katz School of Medicine Temple University, Philadelphia, PA, USA 9Center for Biomarker Research in Medicine, CBmed GmbH, Graz, Austria |
Name and contact information for the trial sponsor {5b} | RECARDIO, Inc., 1 Market Street San Francisco, CA 94150, USA. |
Role of sponsor {5c} | D.N. and S.H. are employees of the funder and were involved in designing the study and reviewing the manuscript. |