Tezosentan in the Treatment of Acute Heart Failure (VERITAS 2)
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ClinicalTrials.gov Identifier: NCT00524433 |
Recruitment Status :
Completed
First Posted : September 3, 2007
Last Update Posted : July 10, 2018
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Tracking Information | |||
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First Submitted Date ICMJE | August 31, 2007 | ||
First Posted Date ICMJE | September 3, 2007 | ||
Last Update Posted Date | July 10, 2018 | ||
Study Start Date ICMJE | April 2003 | ||
Actual Primary Completion Date | January 2005 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Incidence of death or worsening heart failure [ Time Frame: within 7 days following study drug initiation ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
Patient's dyspnea assessment, measured using a visual analog scale [ Time Frame: Over first 24 hours ] | ||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Tezosentan in the Treatment of Acute Heart Failure | ||
Official Title ICMJE | Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure. | ||
Brief Summary | 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
713 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | January 2005 | ||
Actual Primary Completion Date | January 2005 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Australia, Czechia, Germany, Hungary, Italy, Norway, United Kingdom, United States | ||
Removed Location Countries | Czech Republic | ||
Administrative Information | |||
NCT Number ICMJE | NCT00524433 | ||
Other Study ID Numbers ICMJE | AC-051-307 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Idorsia Pharmaceuticals Ltd. | ||
Study Sponsor ICMJE | Idorsia Pharmaceuticals Ltd. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Idorsia Pharmaceuticals Ltd. | ||
Verification Date | July 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |