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

• ClinicalTrials.gov Identifier: NCT00303498
• Recruitment Status: Completed
• First Posted: March 17, 2006
• Last Update Posted: October 11, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00303498
• Other Study ID Numbers: B1321006; FDHF01
• First Posted: March 17, 2006
• Last Update Posted: October 11, 2012
• Last Verified: October 2012

Additional relevant MeSH terms:

Heart Failure; Heart Failure, Diastolic; Heart Diseases; Cardiovascular Diseases; Sitaxsentan; Endothelin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action