A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
NCT ID: NCT00303498
Last Updated: 2023-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2006-03-27
2008-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sitaxsentan sodium
Sitexsentin sodium
sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months
Placebo
Placebo
placebo identical to the study drug in description, dose and duration
Interventions
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Sitexsentin sodium
sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months
Placebo
placebo identical to the study drug in description, dose and duration
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mobile Heart Specialists, PC
Mobile, Alabama, United States
Preventative and Research Cardiloogy Providence Hospital
Mobile, Alabama, United States
Central Arkansas Veterans HCS
Little Rock, Alaska, United States
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States
Parkview Research Center
Tucson, Arizona, United States
Southwest Heart
Tucson, Arizona, United States
University of Arkansas for Medical Services/Cardiology Department
Little Rock, Arkansas, United States
University of Southern California Medical Center
Los Angeles, California, United States
Orange County Heart Institute and Research Center
Orange, California, United States
Sacramento Heart & Vascular Medical Associates
Sacramento, California, United States
University of California
San Diego, California, United States
Yale University School of Medicine, Cardiovascular Medicine
New Haven, Connecticut, United States
Capital City Research, CCRW
Washington D.C., District of Columbia, United States
Florida Heart Group Pa
Orlando, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Methodist Medical Center
Peoria, Illinois, United States
Cardiovascular Consultants of Maine
Auburn, Maine, United States
Massachusetts General Hospital Pulmonary and Critical Care Unit
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
VA Med Ctr Minneapolis
Minneapolis, Minnesota, United States
St. Louis University Hospital
St Louis, Missouri, United States
Washington Univ. School of Medicine
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Catholic Medical Center d/b/a New England Heart Institute
Manchester, New Hampshire, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Buffalo Cardipul Assoc
Buffalo, New York, United States
Columbia University Medical Center, New York Presbyterian Hospital
New York, New York, United States
Capital Cardiology Associates
Troy, New York, United States
Mid Carolina Cardiology
Charlotte, North Carolina, United States
Mid Carolina Cardiology
Huntersville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States
The Oregon Clinic
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Advanced Heart Failure & Transplant Center
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
RHJ VA Medical Center
Charleston, South Carolina, United States
Black Hills Clinical Research Center
Rapid City, South Dakota, United States
Stern Cardiovascular Center
Germantown, Tennessee, United States
Baylor College of Medicine Pulmonary Section
Houston, Texas, United States
Kelsey Seybold Clinic
Houston, Texas, United States
Methodist DeBakey Heart Center
Houston, Texas, United States
Intermountain Medical Center (a.k.a. LDS Hospital)
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Medical College of Virginia
Richmond, Virginia, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
St Michael's Hospital
Toronto, Ontario, Canada
SMBD Jewish General Hospital
Montreal, Quebec, Canada
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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FDHF01
Identifier Type: OTHER
Identifier Source: secondary_id
B1321006
Identifier Type: -
Identifier Source: org_study_id
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