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

Last updated on November 21, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diastolic Heart Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00303498
Pfizer
Completed
A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure

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Descriptive Information
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 SummaryThe 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 DescriptionNot 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
  • 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
  • Drug: Placebo
    placebo identical to the study drug in description, dose and duration
Study Arms  ICMJE
  • Experimental: Sitaxsentan sodium
    Intervention: Drug: Sitaxsentan sodium
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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
 (submitted: July 12, 2011)
192
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion DateMay 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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