VERITAS 2
Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.
Sponsor study identifier
interventional
713
8 countries
42
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2005
Actual (reported)Study Completion
January 2005
Actual (reported)The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
January 2005
Actual (reported)January 2005
Actual (reported)August 31, 2007
Actual (reported)September 3, 2007
Actual (reported)Incidence of death or worsening heart failure
within 7 days following study drug initiation
Patient's dyspnea assessment, measured using a visual analog scale
Over first 24 hours
tezosentan
tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4 mL/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Oracle Research
Huntsville, Alabama, United States
USC Medical Center
Los Angeles, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University of Miami-Jackson Memorial Hospital
Miami, Florida, United States
University Hospital
Augusta, Georgia, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Medical Research Institute
Slidell, Louisiana, United States
Cotter G, Davison BA, Milo O, Bourge RC, Cleland JG, Jondeau G, Krum H, O'Connor CM, Metra M, Parker JD, Torre-Amione G, van Veldhuisen DJ, Kobrin I, Rainisio M, Senger S, Edwards C, McMurray JJ, Teerlink JR; VERITAS Investigators. Predictors and Associations With Outcomes of Length of Hospital Stay in Patients With Acute Heart Failure: Results From VERITAS. J Card Fail. 2016 Oct;22(10):815-22. doi: 10.1016/j.cardfail.2015.12.017. Epub 2015 Dec 22.
McMurray JJ, Teerlink JR, Cotter G, Bourge RC, Cleland JG, Jondeau G, Krum H, Metra M, O'Connor CM, Parker JD, Torre-Amione G, van Veldhuisen DJ, Lewsey J, Frey A, Rainisio M, Kobrin I; VERITAS Investigators. Effects of tezosentan on symptoms and clinical outcomes in patients with acute heart failure: the VERITAS randomized controlled trials. JAMA. 2007 Nov 7;298(17):2009-19. doi: 10.1001/jama.298.17.2009.
713 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2007
First Posted
September 3, 2007
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Baystate Medical Center-Cardiology Section
Springfield, Massachusetts, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Columbia Presbyterian Medical Center-Heart Failure Center
New York, New York, United States
New York University School of Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
Baylor College of Medicine - Texas Medical Center
Houston, Texas, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Alfred Hospital, Monash University, Central and Eastern School
Prahran, Victoria, Australia
Concord Repatriation Hospital
Concord NSW, Australia
Queen Elizabeth Hospital
Woodville SA, Australia
Faculty Hospital St. Anna
Brno, Czechia
Krajska Nemocnice Liberec
Liberec, Husova 10, Czechia
Klinika Kardiologie IKEM
Prague, Czechia
University Hospital Vinohrady (FNKV)
Prague, Czechia
Masaryk Hospital
Ústí nad Labem, Czechia
Universitatsklinikum der Humboldt-Universitat Berlin, Campus Charite Mitte, Med. Klinik und Poliklinik, Kardiologie
Berlin, Germany
Universitat Greifswald, Klinik fur Innere Medizin B
Greifswald, Germany
Asklepios Klinik Langen, Abteilung fur Innere Medizin
Langen, Germany
Universitatsklinikum Schleswig Holstein, Medizinische Klinik II, Kardiologie
Lübeck, Germany
Klinik u. Poliklinik F. Inn. Med. II, Univ. Klinik Regensburg
Regensburg, Germany
Jahn Ferenc, Delpesti Korhaz
Budapest, Hungary
Polyclinic of the Hospitaler Brothers of St. John of God
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
2nd Department of Medicine & Cardiology Centre
Szeged, Hungary
Cattedra di Cardiologia, c/o Spedali Civili
Brescia, Italy
Istituto Clinico Humanitas, U.O. Cardiologia Clin. E Insuff. Cardiaca
Rozzano (MI), Italy
Sentralsykehuset i More og Romsdal, Dept. of Cardiology
Ålesund, Norway
Aker University Hospital, Div. Cardiology
Oslo, Norway
Central Hospital in Rogaland, Cardiology Division
Stavanger, Norway
University Department of Medicine, City Hospital
Birmingham, United Kingdom
Cardiology Department, Bridlington & District Hospital
Bridlington, United Kingdom
University of Glasgow West
Glasgow, United Kingdom
Dept. of Medicine & Therapeutics, University of Leicester
Leicester, United Kingdom
Primary Completion
January 2005
Actual (reported)Study Completion
January 2005
Actual (reported)Last Updated
July 10, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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