You are here

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

Last updated on May 12, 2018

FOR MORE INFORMATION
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
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
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%.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diastolic Heart Failure
  • 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
  • Experimental: Sitaxsentan sodium
    Intervention: Drug: Sitaxsentan sodium
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.
 
Completed
192
May 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00303498
B1321006
FDHF01
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now