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A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303498
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : October 11, 2012
Information provided by (Responsible Party):

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%.

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Drug: Sitaxsentan sodium Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Sitaxsentan sodium Drug: Sitaxsentan 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 Comparator: Placebo Drug: Placebo
placebo identical to the study drug in description, dose and duration

Primary Outcome Measures :
  1. change in treadmill exercise time from baseline [ Time Frame: Baseline and month 24 ]

Secondary Outcome Measures :
  1. Change in the ratio of E/E' measured by Doppler ECHO and TDI [ Time Frame: Baseline and month 24 ]
  2. Change in left ventricular mass measured by ECHO [ Time Frame: Baseline and month 24 ]
  3. Change in Quality of Life Assessment as measured by the MLHF [ Time Frame: Baseline and month 24 ]
  4. Change in NYHA Functional Class [ Time Frame: Baseline and month 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00303498

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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Alaska
Pfizer Investigational Site
Little Rock, Alaska, United States, 72205
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
Pfizer Investigational Site
Tucson, Arizona, United States, 85715
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
Sacramento, California, United States, 95825
Pfizer Investigational Site
San Diego, California, United States, 92103-8411
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20011
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32803
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
Pfizer Investigational Site
Peoria, Illinois, United States, 61606
United States, Maine
Pfizer Investigational Site
Auburn, Maine, United States, 04210
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55417-2309
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Pfizer Investigational Site
Manchester, New Hampshire, United States, 03102
United States, New Jersey
Pfizer Investigational Site
Newark, New Jersey, United States, 07112
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14221-5838
Pfizer Investigational Site
New York, New York, United States, 10032
Pfizer Investigational Site
Troy, New York, United States, 112180
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28204-3288
Pfizer Investigational Site
Huntersville, North Carolina, United States, 28078
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27157-1045
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43210-1252
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97220
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19141
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29401
United States, South Dakota
Pfizer Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Pfizer Investigational Site
Germantown, Tennessee, United States, 38138
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Utah
Pfizer Investigational Site
Murray, Utah, United States, 84157
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Vermont
Pfizer Investigational Site
Burlington, Vermont, United States, 05401
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23298
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5B1W8
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT00303498    
Other Study ID Numbers: B1321006
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action