200
Participants
Start Date
March 27, 2006
Primary Completion Date
May 1, 2008
Study Completion Date
May 1, 2008
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
Columbia University Medical Center, New York Presbyterian Hospital, New York
Allegheny General Hospital, Pittsburgh
University of Pennsylvania, Philadelphia
Advanced Heart Failure & Transplant Center, Philadelphia
Albert Einstein Medical Center, Philadelphia
Capital City Research, CCRW, Washington D.C.
Medical College of Virginia, Richmond
Mid Carolina Cardiology, Huntersville
RHJ VA Medical Center, Charleston
Florida Heart Group Pa, Orlando
University of Alabama at Birmingham, Birmingham
Mobile Heart Specialists, PC, Mobile
Preventative and Research Cardiloogy Providence Hospital, Mobile
Stern Cardiovascular Center, Germantown
University of Wisconsin Hospital & Clinics, Madison
Black Hills Clinical Research Center, Rapid City
The University of Chicago, Chicago
Methodist Medical Center, Peoria
St. Louis University Hospital, St Louis
Washington Univ. School of Medicine, St Louis
Nebraska Heart Institute, Lincoln
Central Arkansas Veterans HCS, Little Rock
University of Arkansas for Medical Services/Cardiology Department, Little Rock
Oklahoma Foundation for Cardiovascular Research, Oklahoma City
Baylor College of Medicine Pulmonary Section, Houston
Kelsey Seybold Clinic, Houston
Methodist DeBakey Heart Center, Houston
University of Utah, Salt Lake City
Intermountain Medical Center (a.k.a. LDS Hospital), Murray
Arizona Pulmonary Specialists, LTD, Phoenix
Parkview Research Center, Tucson
Southwest Heart, Tucson
University of Southern California Medical Center, Los Angeles
Orange County Heart Institute and Research Center, Orange
Sacramento Heart & Vascular Medical Associates, Sacramento
The Oregon Clinic, Portland
Capital Cardiology Associates, Troy
University of California, San Diego
Yale University School of Medicine, Cardiovascular Medicine, New Haven
Cardiovascular Consultants of Maine, Auburn
Massachusetts General Hospital Pulmonary and Critical Care Unit, Boston
Brigham and Women's Hospital, Boston
VA Med Ctr Minneapolis, Minneapolis
Catholic Medical Center d/b/a New England Heart Institute, Manchester
Newark Beth Israel Medical Center, Newark
Buffalo Cardipul Assoc, Buffalo
Mid Carolina Cardiology, Charlotte
Wake Forest University Health Sciences, Winston-Salem
The Ohio State University, Columbus
Fletcher Allen Health Care, Burlington
St Michael's Hospital, Toronto
SMBD Jewish General Hospital, Montreal
Lead Sponsor
Pfizer
INDUSTRY