A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
NCT00303498
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- 18 or older with chronic heart failure and evidence of diastolic dysfunction on echocardiogram, heart imaging, and a minimum exercise tolerance average time of 120 seconds on two treadmill tests within 2 weeks of enrollment
- unstable cardiovascular disease within 4 weeks of screening, history of heart attack,
cardiac by-pass surgery or percutaneous intervention, stent placement, within 3 months
of screening or amyloidosis, hypertrophic obstructive or restrictive cardiomyopathy,
or constrictive pericarditis
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Descriptive Information | ||||
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Brief Title ICMJE | A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure | |||
Official Title ICMJE | A Phase 2 Randomised, Double-Blind, Placebo-Controlled Exploratory Efficacy Study Of Sitaxsentan Sodium To Improve Impaired Exercise Tolerance In Subjects With Diastolic Heart Failure | |||
Brief Summary | The aim of this study was to determine whether long-term (? 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ?50%. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Diastolic Heart Failure | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Zile MR, Bourge RC, Redfield MM, Zhou D, Baicu CF, Little WC. Randomized, double-blind, placebo-controlled study of sitaxsentan to improve impaired exercise tolerance in patients with heart failure and a preserved ejection fraction. JACC Heart Fail. 2014 Apr;2(2):123-30. doi: 10.1016/j.jchf.2013.12.002. Epub 2014 Feb 26. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 192 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | May 2008 | |||
Actual Primary Completion Date | May 2008 (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 | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00303498 | |||
Other Study ID Numbers ICMJE | B1321006 FDHF01 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | October 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |