Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
60 participants
INTERVENTIONAL
2022-05-26
2023-07-25
Brief Summary
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Part B of the study was not conducted in favor of redesigned new studies.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CRD-740
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks.
CRD-740
Tablets administered orally.
Placebo
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.
Placebo
Tablets administered orally.
Interventions
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CRD-740
Tablets administered orally.
Placebo
Tablets administered orally.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of clinical heart failure syndrome, New York Heart Association functional class II - III for at least 6 months prior to screening
3. For Part A:
* Ejection Fraction ≤40% by echocardiography at screening.
* NT-proBNP level ≥600 pg/ml at screening. Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥1000 pg/mL at screening.
5\. Stable doses of guideline-directed heart failure therapy for a minimum of 4 weeks prior to screening that has been individually optimized according to standard practice guidelines and no addition of guideline-directed heart failure therapy within 3 months of screening.
Exclusion Criteria
3\. Subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study.
4\. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening.
5\. Subjects with clinical suspicion of infiltrative cardiomyopathy (e.g., amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.
6\. Prior or planned orthotopic heart transplantation.
7\. Presence of or plan for mechanical circulatory support.
18 Years
ALL
No
Sponsors
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Cardurion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Surks, MD
Role: STUDY_DIRECTOR
Chief Medical and Scientific Officer
Locations
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Cardurion Investigative Site
Alexander City, Alabama, United States
Cardurion Investigative Site
Birmingham, Alabama, United States
Cardurion Investigative Site
Fairhope, Alabama, United States
Cardurion Investigative Site
Torrance, California, United States
Cardurion Investigative Site
Hialeah, Florida, United States
Cardurion Investigative Site
Miami, Florida, United States
Cardurion Investigative Site
Miami, Florida, United States
Cardurion Investigative Site
Naples, Florida, United States
Cardurion Investigative Site
Tampa, Florida, United States
Cardurion Investigative Site
Atlanta, Georgia, United States
Cardurion Investigative Site
Hazel Crest, Illinois, United States
Cardurion Investigative Site
Alexandria, Louisiana, United States
Cardurion Investigative Site
Minneapolis, Minnesota, United States
Cardurion Investigative Site
Greensboro, North Carolina, United States
Cardurion Investigative Site
Tullahoma, Tennessee, United States
Cardurion Investigative Site
Allen, Texas, United States
Cardurion Investigative Site
Norfolk, Virginia, United States
Cardurion Investigative Site
Winnepeg, Manitoba, Canada
Cardurion Investigative Site
Ashkelon, , Israel
Cardurion Investigative Site
Be’er Ya‘aqov, , Israel
Cardurion Investigative Site
Haifa, , Israel
Cardurion Investigative Site
Haifa, , Israel
Cardurion Investigative Site
Nahariya, , Israel
Cardurion Investigative Site
Rehovot, , Israel
Cardurion Investigative Site
Tiberias, , Israel
Cardurion Investigative Site
High Wycombe, Buckinghamshire, United Kingdom
Cardurion Investigative Site
Airdrie, Lanarkshire, United Kingdom
Cardurion Investigative Site
Isleworth, Middlesex, United Kingdom
Cardurion Investigative Site
Clydebank, , United Kingdom
Cardurion Investigative Site
Dundee, , United Kingdom
Cardurion Investigative Site
Glasgow, , United Kingdom
Cardurion Investigative Site
Harrow, , United Kingdom
Cardurion Investigative Site
Newcastle upon Tyne, , United Kingdom
Cardurion Investigative Site
Stockton-on-Tees, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CRD-740-201
Identifier Type: -
Identifier Source: org_study_id